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

Air Force Military Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 3

Conditions: Glomerulonephritis, IGA

Treatments: Drug: Prednisolone plus Cyclophosphamide; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05510323

KY20222108-F-1

Details and patient eligibility

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

208 participants in 2 patient groups

CS

Active Comparator group

Description:

low-dose corticosteroids monotherapy

Treatment:

Drug: Prednisolone

CS+CTX

Active Comparator group

Description:

low-dose corticosteroids combined with cyclophosphamide

Treatment:

Drug: Prednisolone plus Cyclophosphamide