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

Phase 3

Recruiting

• Conditions: Glomerulonephritis, IGA
• Interventions: Drug: Prednisolone plus Cyclophosphamide; Drug: Prednisolone

• Registration Number: NCT05510323
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2024-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS+CTX	Prednisolone plus Cyclophosphamide	low-dose corticosteroids combined with cyclophosphamide
CS	Prednisolone	low-dose corticosteroids monotherapy

Primary Outcome Measures

Name	Time	Method
Combined event	up to 6 years	40% decrease in eGFR, ESRD or death due to kidney disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AFMMU; 🇨🇳 Xi'an, China