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Efficacy and Safety in Chinese Patients With Immunoglobulin A Nephropathy (IgAN) Who Have Completed Study Nef-301

Primary Purpose

Primary Immunoglobulin A Nephropathy (IgAN)

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nefecon
Sponsored by
Everest Medicines (Singapore) Pte. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients that completed study Nef-301.
  2. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
  3. Willing and able to provide written informed consent.
  4. Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day.
  5. eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

  1. Systemic diseases that may cause mesangial Immunoglobulin A (IgA) deposition.
  2. Patients who have undergone a kidney transplant.
  3. Patients with presence of other glomerulopathies and/or nephrotic syndrome.
  4. Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections.
  5. Patients with liver cirrhosis, as assessed by the Investigator.
  6. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
  7. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator.
  8. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
  9. Patients with diagnosed malignancy within the past 5 years.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nefecon active treatment

Arm Description

Nefecon 16mg once daily for 9 months.

Outcomes

Primary Outcome Measures

Change in urine protein to creatinine ratio (UPCR) after 9 months
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
Change in estimated glomerular filtration rate(eGFR) at 9 months
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
The incidence of treatment emergent adverse events
Adverse event data collection

Secondary Outcome Measures

Full Information

First Posted
September 6, 2022
Last Updated
September 19, 2022
Sponsor
Everest Medicines (Singapore) Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05534919
Brief Title
Efficacy and Safety in Chinese Patients With Immunoglobulin A Nephropathy (IgAN) Who Have Completed Study Nef-301
Official Title
An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Ompleted Study Nef-301 in China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Everest Medicines (Singapore) Pte. Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
Detailed Description
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is an open label, single-arm study with active treatment.
Masking
None (Open Label)
Masking Description
This is an open label, single-arm study with active treatment.
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nefecon active treatment
Arm Type
Experimental
Arm Description
Nefecon 16mg once daily for 9 months.
Intervention Type
Drug
Intervention Name(s)
Nefecon
Intervention Description
Nefecon is taken orally as capsules once daily for 9 months.
Primary Outcome Measure Information:
Title
Change in urine protein to creatinine ratio (UPCR) after 9 months
Description
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
Time Frame
9 months
Title
Change in estimated glomerular filtration rate(eGFR) at 9 months
Description
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
Time Frame
9 months
Title
The incidence of treatment emergent adverse events
Description
Adverse event data collection
Time Frame
from enrollment up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients that completed study Nef-301. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Willing and able to provide written informed consent. Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day. eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Exclusion Criteria: Systemic diseases that may cause mesangial Immunoglobulin A (IgA) deposition. Patients who have undergone a kidney transplant. Patients with presence of other glomerulopathies and/or nephrotic syndrome. Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections. Patients with liver cirrhosis, as assessed by the Investigator. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator. Patients with diagnosed malignancy within the past 5 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Liu
Phone
00862180123250
Email
yuan.liu@everestmedicines.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jicheng Lv, Doctor degree
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jicheng Lv, Doctor degree
Phone
00861083572611
Email
chenglv@263.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety in Chinese Patients With Immunoglobulin A Nephropathy (IgAN) Who Have Completed Study Nef-301

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