Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Recruiting
Phase 3
Interventional Study
Glomerulonephritis, IGA
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 208 (estimated)
- Sponsor
- Air Force Military Medical University, China · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
Contacts
No contact information available.