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Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

Primary Purpose

IgA Nephropathy

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

LNP023

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring LNP023, IgA nephropathy, IgAN, proteinuria, UPCR, eGFR, eGFR slope, kidney function decline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows:
For patients eGFR* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required.
For patients with eGFR* 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required.
For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time.

In all cases, if a historical biopsy is not available, one may be performed during screening. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline.
Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
If not previously vaccinated, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days before first study drug administration. In addition, if patients are taking diuretics, other antihypertensive medication, or other background medication for IgAN, the doses should also be stabilized for approximately 90 days prior to the first dosing of study treatment.

Exclusion Criteria:

Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc.
Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit
Patients previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration
Prior use of LNP023 or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo
History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LNP023 200mg b.i.d

Placebo to LNP023 200mg b.i.d

Arm Description

Outcomes

Primary Outcome Measures

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months

Evaluated at interim analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein to Creatinine Ratio sampled from a 24h urine collection.

Annualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).

Evaluated at the final analysis - to demonstrate superiority of LNP023 vs. placebo in slowing IgAN progression measured by the annualized total slope of Estimated Glomerular Filtration Rate (eGFR) change over 24 months.

Secondary Outcome Measures

Change from baseline in estimated glomerular filtration rate at 9 months

Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing estimated glomerular filtration rate decrease as measured by the change from baseline in eGFR

Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant or other newly approved drugs or initiating new background therapy for treatment of IgAN or Kidney Replacement Therapy (KRT)

Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.

Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months

Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing IgAN progression measured by the annualized total slope of Estimated Glomerular Filtration Rate change over 1 year.

Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire

Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the change from baseline to 9 months in fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

Time from randomization to first occurrence of composite kidney failure endpoint event

Evaluated at final analysis - demonstrate the superiority of LNP023 vs. placebo on delaying the time to first occurrence of a composite kidney failure endpoint, defined as reaching either sustained ≥30% decline in Estimated Glomerular Filtration Rate (eGFR) relative to baseline or sustained eGFR <15 mL/min/1.73m2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure.

Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months

Evaluated at final analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein To Creatinine Ratio sampled from a 24h urine collection.

Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant Therapy or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT

Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.

Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the change from baseline to 9 months in the fatigue scale measured by Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

Full Information

NCT ID

NCT04578834

First Posted

September 9, 2020

Last Updated

September 27, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04578834

Brief Title

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

Acronym

APPLAUSE-IgAN

Official Title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2021 (Actual)

Primary Completion Date

January 7, 2025 (Anticipated)

Study Completion Date

October 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Detailed Description

The purpose of the study is to evaluate the efficacy and safety of iptacopan (LNP023) compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months. The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. The trial will enroll approximately 470 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and up to approximately 40 participants with eGFR 20 to <30 mL/min/1.73m2 (severe renal impairment (SRI) population).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgA Nephropathy

Keywords

LNP023, IgA nephropathy, IgAN, proteinuria, UPCR, eGFR, eGFR slope, kidney function decline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LNP023 200mg b.i.d

Arm Type

Experimental

Arm Title

Placebo to LNP023 200mg b.i.d

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to LNP023 200mg b.i.d

Intervention Type

Drug

Intervention Name(s)

LNP023

Other Intervention Name(s)

iptacopan

Intervention Description

LNP023 200mg b.i.d

Primary Outcome Measure Information:

Title

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months

Description

Time Frame

Baseline and 9 months

Title

Annualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).

Description

Time Frame

Baseline and 24 months

Secondary Outcome Measure Information:

Title

Change from baseline in estimated glomerular filtration rate at 9 months

Description

Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing estimated glomerular filtration rate decrease as measured by the change from baseline in eGFR

Time Frame

Baseline and 9 months

Title

Description

Time Frame

Baseline and 9 months

Title

Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months

Description

Time Frame

Baseline and 12 months

Title

Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire

Description

Time Frame

Baseline and 9 months

Title

Time from randomization to first occurrence of composite kidney failure endpoint event

Description

Time Frame

Up to 24 months

Title

Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months

Description

Time Frame

Baseline and 9 months

Title

Description

Time Frame

Baseline and 9 months

Title

Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

Description

Time Frame

Baseline and 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows: For patients eGFR* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required. For patients with eGFR* 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required. For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time. In all cases, if a historical biopsy is not available, one may be performed during screening. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines) Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. If not previously vaccinated, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration. All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days before first study drug administration. In addition, if patients are taking diuretics, other antihypertensive medication, or other background medication for IgAN, the doses should also be stabilized for approximately 90 days prior to the first dosing of study treatment. Exclusion Criteria: Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc. Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit Patients previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration. Prior use of iptacopan (LNP023) or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus. Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration. Other protocol-defined inclusion/exclusion criteria may apply.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

El Centro

State/Province

California

ZIP/Postal Code

92243

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92844

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

S. Gate

State/Province

California

ZIP/Postal Code

90280

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Salinas

State/Province

California

ZIP/Postal Code

93901

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

California

ZIP/Postal Code

91355

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Chubbuck

State/Province

Idaho

ZIP/Postal Code

83202

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Hinsdale

State/Province

Illinois

ZIP/Postal Code

60521

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

80808

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39501

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Jersey City

State/Province

New Jersey

ZIP/Postal Code

07305

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229 3900

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76502

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84115

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

1426

Country

Argentina

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016JDA

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000EPV

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

ZIP/Postal Code

30150-221

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

ZIP/Postal Code

80440-020

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

04038-002

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

ZIP/Postal Code

15090 000

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Temuco

ZIP/Postal Code

4790084

Country

Chile

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

102218

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Haikou

State/Province

Hainan

ZIP/Postal Code

570311

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Luoyang

State/Province

Henan

ZIP/Postal Code

471003

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130041

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Yinchuan

State/Province

Ningxia

ZIP/Postal Code

100039

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030001

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710004

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Urumqi

State/Province

Xinjiang

ZIP/Postal Code

830001

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wulumuqi

State/Province

Xinjiang

ZIP/Postal Code

830054

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Guang Zhou

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ningbo

ZIP/Postal Code

315010

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Qingdao

ZIP/Postal Code

266000

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Shanxi

ZIP/Postal Code

710063

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Shenzhen

ZIP/Postal Code

518036

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Zhejiang

ZIP/Postal Code

315016

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050001

Country

Colombia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Arhus N

ZIP/Postal Code

DK-8200

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

HUS

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13385

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 017

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560004

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500058

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

DehraDun

State/Province

Uttarakhand

ZIP/Postal Code

248001

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

310 9601

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ranica

State/Province

ZIP/Postal Code

24020

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rome

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kasugai

State/Province

Aichi

ZIP/Postal Code

486-8510

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Toyoake city

State/Province

Aichi

ZIP/Postal Code

470 1192

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Toyota

State/Province

Aichi

ZIP/Postal Code

471-8513

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Chiba-city

State/Province

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kitakyushu-city

State/Province

Fukuoka

ZIP/Postal Code

802-8555

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

006-8555

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kahoku-gun

State/Province

Ishikawa

ZIP/Postal Code

920-0293

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

213-8587

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

224-8503

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

981-3205

Country

Japan

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tomigusuku

State/Province

Okinawa

ZIP/Postal Code

901-0224

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

530-0012

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

530-8480

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

558-8558

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Omihachiman

State/Province

Shiga

ZIP/Postal Code

523-0082

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bunkyo ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

605-0981

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Niigata

ZIP/Postal Code

951 8520

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oita

ZIP/Postal Code

870-0033

Country

Japan

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Toyama

ZIP/Postal Code

930-8550

Country

Japan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03312

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

47392

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

134 727

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Taegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

50589

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California Norte

ZIP/Postal Code

21200

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cdmx

ZIP/Postal Code

03100

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Culiacan Sinaloa

ZIP/Postal Code

80230

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nordbyhagen

State/Province

Oslo

ZIP/Postal Code

1478

Country

Norway

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119881

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Omsk

ZIP/Postal Code

644112

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Rostov On Don

ZIP/Postal Code

344022

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

833 05

Country

Slovakia

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sala

ZIP/Postal Code

92719

Country

Slovakia

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Burela

State/Province

Lugo

ZIP/Postal Code

27880

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Danderyd

ZIP/Postal Code

182 88

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Linkoping

ZIP/Postal Code

581 85

Country

Sweden

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

New Taipei

ZIP/Postal Code

22060

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ankara

State/Province

Cankaya

ZIP/Postal Code

06100

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

Sultangazi

ZIP/Postal Code

34265

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34371

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

State/Province

VNM

ZIP/Postal Code

700000

Country

Vietnam

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

35675911

Citation

Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.

Results Reference

derived

Learn more about this trial

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

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Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

IgA Nephropathy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial