Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

May 3, 2024 updated by: Shiren sun, Air Force Military Medical University, China

Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease

The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy-proven IgA nephropathy;
  • Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
  • Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.

Exclusion Criteria:

  • Indication or contraindication for immunosuppressive therapy with corticosteroids
  • Use of corticosteroids and other immunosuppressive drugs within the last 1 year
  • Current unstable kidney function for other reasons
  • Under 18 years old
  • Patients with secondary IgAN
  • Patients who are unlikely to comply with the study protocol in the view of the treating physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CS
low-dose corticosteroids monotherapy
Drug: Prednisolone
RAS blockade as much as tolerated or allowed
Active Comparator: CS+CTX
low-dose corticosteroids combined with cyclophosphamide
Drug: Prednisolone plus Cyclophosphamide
RAS blockade as much as tolerated or allowed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined event
Time Frame: up to 6 years
40% decrease in eGFR, ESRD or death due to kidney disease
up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteinuria remission at 6, 12 months and total follow-up period
Time Frame: up to 6 years
Proteinuria remission
up to 6 years
Hematuria remission at 6, 12 months and total follow-up period
Time Frame: up to 6 years
Hematuria remission
up to 6 years
The composite of 30% decrease in eGFR, ESRD and all cause death
Time Frame: up to 6 years
up to 6 years
The composite of 40% decrease in eGFR, ESRD and all cause death
Time Frame: up to 6 years
up to 6 years
The composite of 50% decrease in eGFR, ESRD and all cause death
Time Frame: up to 6 years
up to 6 years
Annual eGFR decline rate
Time Frame: up to 6 years
up to 6 years
30% decrease in eGFR
Time Frame: up to 6 years
up to 6 years
40% decrease in eGFR
Time Frame: up to 6 years
up to 6 years
50% decrease in eGFR
Time Frame: up to 6 years
up to 6 years
ESRD
Time Frame: up to 6 years
up to 6 years
All cause death
Time Frame: up to 6 years
up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20222108-F-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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