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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05510323

Enrollment

208

Registered

2022-08-22

Start date

2024-02-01

Completion date

2028-08-31

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerulonephritis, IGA

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.

Interventions

DRUGPrednisolone

RAS blockade as much as tolerated or allowed

DRUGPrednisolone plus Cyclophosphamide

RAS blockade as much as tolerated or allowed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Combined event	up to 6 years	40% decrease in eGFR, ESRD or death due to kidney disease

Secondary

Measure	Time frame	Description
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	—
Proteinuria remission at 6, 12 months and total follow-up period	up to 6 years	Proteinuria remission
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	—
30% decrease in eGFR	up to 6 years	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026