search
Back to results

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)

Primary Purpose

Immunoglobulin A Nephropathy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sparsentan
irbesartan
Dapagliflozin
Sponsored by
Travere Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunoglobulin A Nephropathy

Eligibility Criteria

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

Key Inclusion Criteria for the Double-Blind Period:

  • Age 18 years or older at screening
  • Biopsy-proven primary IgAN
  • Proteinuria of ≥1 g/day at screening
  • eGFR ≥30 mL/min/1.73 m2 at screening
  • Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)
  • Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening
  • Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications
  • Agree to contraception

Key Exclusion Criteria for the Double-Blind Period:

  • IgAN secondary to another condition
  • Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)
  • Chronic kidney disease (CKD) in addition to IgAN
  • History of organ transplantation, with exception of corneal transplants
  • Require any prohibited medications
  • Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening
  • History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema
  • Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening
  • Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening
  • History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
  • Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening
  • Potassium >5.5 mEq/L (5.5 mmol/L) at Screening
  • History of alcohol of illicit drug use disorder
  • History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications
  • For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding
  • Participation in a study of another investigational product within 28 days of screening

Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit:

  • Completed participation in the double-blind period, including the Week 114 visit
  • Did not permanently discontinue study medication during the double-blind period
  • Agree to contraception

Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits:

  • Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)
  • Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114
  • Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114
  • eGFR ≤20 mL/min/1.73 m2 at Week 110
  • Female patient is pregnant or breastfeeding

Sites / Locations

  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site
  • Travere Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

sparsentan

irbesartan

dapagliflozin + sparsentan (Sub study)

sparsentan (Sub Study)

Arm Description

Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.

Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.

OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.

OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.

Outcomes

Primary Outcome Measures

Urine protein/creatinine ratio (UP/C) at Week 36
The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C based on a 24-hour urine sample at Week 36.

Secondary Outcome Measures

eGFR over a 52-week period
The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 58 weeks postrandomization eGFR chronic slope at 1 year.)
eGFR over a 104-week period
The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 110 weeks postrandomization eGFR chronic slope at 2 years.)
eGFR over a 110-week period
The rate of change in eGFR over a 110-week (approximately 2 years) period following the initiation of randomized therapy (thus, the analysis is from Day 1 to 110 weeks postrandomization eGFR total slope at 2 years).

Full Information

First Posted
November 27, 2018
Last Updated
September 1, 2023
Sponsor
Travere Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03762850
Brief Title
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Acronym
PROTECT
Official Title
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Travere Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
Detailed Description
This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. The purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment. Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose. The primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients. Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study. Patients participating in the open-label extension period may be evaluated for eligibility to participate in a randomized, open-label, controlled Sub study evaluating the safety and efficacy of an SGLT2 inhibitor in addition to stable sparsentan treatment (OLE Sub study). The SGLT2 inhibitor, dapagliflozin will be provided as "study medication" for the OLE Sub study. Following completion of the visit 12 weeks after the OLE baseline visit, eligible patients may receive open-label dapagliflozin for at least 12 weeks but up to 24 additional weeks, or through the end of the open-label extension period, whichever is shortest. Approximately 60 patients from the open-label extension period will be enrolled into the OLE Sub study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sparsentan
Arm Type
Experimental
Arm Description
Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.
Arm Title
irbesartan
Arm Type
Active Comparator
Arm Description
Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.
Arm Title
dapagliflozin + sparsentan (Sub study)
Arm Type
Experimental
Arm Description
OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.
Arm Title
sparsentan (Sub Study)
Arm Type
Experimental
Arm Description
OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
sparsentan
Other Intervention Name(s)
RE-021
Intervention Description
Target dose of 400 mg daily
Intervention Type
Drug
Intervention Name(s)
irbesartan
Other Intervention Name(s)
Irbesartan Tablets USP
Intervention Description
Target dose of 300 mg daily
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Target dose of 10 mg daily
Primary Outcome Measure Information:
Title
Urine protein/creatinine ratio (UP/C) at Week 36
Description
The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C based on a 24-hour urine sample at Week 36.
Time Frame
After the last patient randomized has undergone the Week 36 visit
Secondary Outcome Measure Information:
Title
eGFR over a 52-week period
Description
The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 58 weeks postrandomization eGFR chronic slope at 1 year.)
Time Frame
Week 58 postrandomization
Title
eGFR over a 104-week period
Description
The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 110 weeks postrandomization eGFR chronic slope at 2 years.)
Time Frame
Week 110 postrandomization
Title
eGFR over a 110-week period
Description
The rate of change in eGFR over a 110-week (approximately 2 years) period following the initiation of randomized therapy (thus, the analysis is from Day 1 to 110 weeks postrandomization eGFR total slope at 2 years).
Time Frame
Week 110 postrandomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria for the Double-Blind Period: Age 18 years or older at screening Biopsy-proven primary IgAN Proteinuria of ≥1 g/day at screening eGFR ≥30 mL/min/1.73 m2 at screening Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose) Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications Agree to contraception Key Exclusion Criteria for the Double-Blind Period: IgAN secondary to another condition Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening) Chronic kidney disease (CKD) in addition to IgAN History of organ transplantation, with exception of corneal transplants Require any prohibited medications Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening Potassium >5.5 mEq/L (5.5 mmol/L) at Screening History of alcohol of illicit drug use disorder History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding Participation in a study of another investigational product within 28 days of screening Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit: Completed participation in the double-blind period, including the Week 114 visit Did not permanently discontinue study medication during the double-blind period Agree to contraception Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits: Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT) Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114 Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114 eGFR ≤20 mL/min/1.73 m2 at Week 110 Female patient is pregnant or breastfeeding Key Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study: Participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub study A urine protein excretion value of ≥0.3 g/day. An eGFR of ≥25 mL/min/1.73m2 On a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose. Key Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study: Progressed to ESRD requiring RRT Initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks Taking an SGLT2 inhibitor within 12 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila Preciado, MD
Organizational Affiliation
Travere Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Travere Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Travere Investigational Site
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Travere Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Travere Investigational Site
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Travere Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Travere Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
Country
United States
Facility Name
Travere Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Travere Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94205
Country
United States
Facility Name
Travere Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Travere Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Travere Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Travere Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Travere Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Travere Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Travere Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Travere Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Travere Investigational Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Travere Investigational Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Travere Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Travere Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Travere Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Travere Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Travere Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Travere Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Travere Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Travere Investigational Site
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Travere Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Travere Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Travere Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Travere Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Travere Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Travere Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Travere Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Travere Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Travere Investigational Site
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Travere Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Travere Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Travere Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Travere Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Travere Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Travere Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Travere Investigational Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Travere Investigational Site
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Travere Investigational Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Travere Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Travere Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Travere Investigational Site
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Travere Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Travere Investigational Site
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
Travere Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Travere Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Travere Investigational Site
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Travere Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Travere Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Travere Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Travere Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Travere Investigational Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Travere Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Travere Investigational Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Travere Investigational Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Travere Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Travere Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Travere Investigational Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Travere Investigational Site
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
Travere Investigational Site
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Travere Investigational Site
City
Grenoble Cedex 9
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Facility Name
Travere Investigational Site
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
Travere Investigational Site
City
Paris Cedex 15
State/Province
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Travere Investigational Site
City
Clermont Ferrand Cedex
State/Province
Puy De Dome
ZIP/Postal Code
63003
Country
France
Facility Name
Travere Investigational Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Travere Investigational Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Travere Investigational Site
City
Villingen-Schwenningen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
78052
Country
Germany
Facility Name
Travere Investigational Site
City
Hanover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Travere Investigational Site
City
Duesseldorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40210
Country
Germany
Facility Name
Travere Investigational Site
City
Aachen
State/Province
North Rhine Westphalia
ZIP/Postal Code
52074
Country
Germany
Facility Name
Travere Investigational Site
City
Kaiserslautern
State/Province
Rheinland Palatinate
ZIP/Postal Code
67655
Country
Germany
Facility Name
Travere Investigational Site
City
Trier
State/Province
Rheinland Palatinate
ZIP/Postal Code
54292
Country
Germany
Facility Name
Travere Investigational Site
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Travere Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Travere Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Travere Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Travere Investigational Site
City
Kwun Tong
State/Province
Kowloon
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Lai Chi Kok
State/Province
Kowloon
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Tsuen Wan
State/Province
New Territories
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Ranica
State/Province
Bergamo
ZIP/Postal Code
24020
Country
Italy
Facility Name
Travere Investigational Site
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Travere Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Travere Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Travere Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Travere Investigational Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Travere Investigational Site
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Travere Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Travere Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Travere Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Travere Investigational Site
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Anyang-Si
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Travere Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Travere Investigational Site
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Travere Investigational Site
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Facility Name
Travere Investigational Site
City
Hastings
ZIP/Postal Code
4120
Country
New Zealand
Facility Name
Travere Investigational Site
City
New Plymouth
ZIP/Postal Code
4342
Country
New Zealand
Facility Name
Travere Investigational Site
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Travere Investigational Site
City
Olsztyn
ZIP/Postal Code
10-124
Country
Poland
Facility Name
Travere Investigational Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Travere Investigational Site
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Travere Investigational Site
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Travere Investigational Site
City
Łódź
ZIP/Postal Code
93-347
Country
Poland
Facility Name
Travere Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Travere Investigational Site
City
Lisboa
ZIP/Postal Code
1069-166
Country
Portugal
Facility Name
Travere Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Travere Investigational Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Travere Investigational Site
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Travere Investigational Site
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Travere Investigational Site
City
Palma De Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Travere Investigational Site
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Travere Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Travere Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Travere Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Travere Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Travere Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Travere Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Travere Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Travere Investigational Site
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Travere Investigational Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Travere Investigational Site
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Travere Investigational Site
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Travere Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Middlesbrough
State/Province
Cleveland
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
State/Province
Greater London
ZIP/Postal Code
E1 4AT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Cardiff
State/Province
West Glamorgan
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://travere.com
Description
Sponsor Website

Learn more about this trial

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

We'll reach out to this number within 24 hrs