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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05510323

Collaborator

(none)

208

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glomerulonephritis, IGA	Drug: Prednisolone Drug: Prednisolone plus Cyclophosphamide	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CS low-dose corticosteroids monotherapy	Drug: Prednisolone RAS blockade as much as tolerated or allowed
Active Comparator: CS+CTX low-dose corticosteroids combined with cyclophosphamide	Drug: Prednisolone plus Cyclophosphamide RAS blockade as much as tolerated or allowed

Arm

Intervention/Treatment

Active Comparator: CS

low-dose corticosteroids monotherapy

Drug: Prednisolone

RAS blockade as much as tolerated or allowed

Active Comparator: CS+CTX

low-dose corticosteroids combined with cyclophosphamide

Drug: Prednisolone plus Cyclophosphamide

RAS blockade as much as tolerated or allowed

Outcome Measures

Primary Outcome Measures

Combined event [up to 6 years]
40% decrease in eGFR, ESRD or death due to kidney disease

Secondary Outcome Measures

Proteinuria remission at 6, 12 months and total follow-up period [up to 6 years]
Proteinuria remission
Hematuria remission at 6, 12 months and total follow-up period [up to 6 years]
Hematuria remission
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]
Annual eGFR decline rate [up to 6 years]
30% decrease in eGFR [up to 6 years]
40% decrease in eGFR [up to 6 years]
50% decrease in eGFR [up to 6 years]
ESRD [up to 6 years]
All cause death [up to 6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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