NCT05510323
Recruiting
Phase 3
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Air Force Military Medical University, China1 site in 1 country208 target enrollmentStarted: February 1, 2024Last updated:
ConditionsGlomerulonephritis, IGA
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Combined event
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CS
Active Comparator
low-dose corticosteroids monotherapy
Intervention: Prednisolone (Drug)
CS+CTX
Active Comparator
low-dose corticosteroids combined with cyclophosphamide
Intervention: Prednisolone plus Cyclophosphamide (Drug)
Outcomes
Primary Outcomes
Combined event
Time Frame: up to 6 years
40% decrease in eGFR, ESRD or death due to kidney disease
Secondary Outcomes
- 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)
- Hematuria remission at 6, 12 months and total follow-up period(up to 6 years)
- 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)
Investigators
Shiren sun
Chief
Air Force Military Medical University, China
Study Sites (1)
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