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

Last updated: May 3, 2024
Sponsor: Air Force Military Medical University, China
Overall Status: Active - Recruiting

Phase

3

Condition

Glomerulonephritis

Treatment

Prednisolone plus Cyclophosphamide

Prednisolone

Clinical Study ID

NCT05510323
KY20222108-F-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thetreating physician

Study Design

Total Participants: 208
Treatment Group(s): 2
Primary Treatment: Prednisolone plus Cyclophosphamide
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • AFMMU

    Xi'an,
    China

    Active - Recruiting

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