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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Prednisolone
DrugRAS blockade as much as tolerated or allowed
Prednisolone plus Cyclophosphamide
DrugRAS blockade as much as tolerated or allowed
Treatment groups
Trial outcomes
Primary outcomes
Combined event
40% decrease in eGFR, ESRD or death due to kidney disease
Secondary outcomes
Proteinuria remission at 6, 12 months and total follow-up period
Proteinuria remission
Hematuria remission at 6, 12 months and total follow-up period
Hematuria remission
The composite of 30% decrease in eGFR, ESRD and all cause death
The composite of 40% decrease in eGFR, ESRD and all cause death
Sponsors and contacts
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