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

NCT05510323 | Recruiting Phase 3

• 1 other identifier: KY20222108-F-1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glomerulonephritis, IGA

Outcome Measures

Primary Outcomes (1)

• Combined event

  40% decrease in eGFR, ESRD or death due to kidney disease

  up to 6 years

Secondary Outcomes (11)

• Proteinuria remission at 6, 12 months and total follow-up period

  up to 6 years

• Hematuria remission at 6, 12 months and total follow-up period

  up to 6 years

• The composite of 30% decrease in eGFR, ESRD and all cause death

  up to 6 years

• The composite of 40% decrease in eGFR, ESRD and all cause death

  up to 6 years

• The composite of 50% decrease in eGFR, ESRD and all cause death

  up to 6 years

Study Arms (2)

CS

ACTIVE COMPARATOR

low-dose corticosteroids monotherapy

Drug: Prednisolone

CS+CTX

ACTIVE COMPARATOR

low-dose corticosteroids combined with cyclophosphamide

Drug: Prednisolone plus Cyclophosphamide

Interventions

Prednisolone DRUG

RAS blockade as much as tolerated or allowed

CS

Prednisolone plus Cyclophosphamide DRUG

RAS blockade as much as tolerated or allowed

CS+CTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

AFMMU

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Prednisolone; Cyclophosphamide

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: February 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

CN (1)