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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glomerulonephritis, IGA

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Prednisolone plus Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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