Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Recruiting · NCT05510323 · Interventional (participants receive a specific treatment) · Lead sponsor: Air Force Military Medical University, China
View the official record on ClinicalTrials.gov →Interventions studied
PrednisolonePrednisolone plus Cyclophosphamide
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- AFMMU - Xi'an, China