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

NCT ID: NCT05510323

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glomerulonephritis, IGA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CS

low-dose corticosteroids monotherapy

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

RAS blockade as much as tolerated or allowed

CS+CTX

low-dose corticosteroids combined with cyclophosphamide

Group Type ACTIVE_COMPARATOR

Prednisolone plus Cyclophosphamide

Intervention Type DRUG

RAS blockade as much as tolerated or allowed

Interventions

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Prednisolone

RAS blockade as much as tolerated or allowed

Intervention Type DRUG

Prednisolone plus Cyclophosphamide

RAS blockade as much as tolerated or allowed

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shiren sun

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AFMMU

Xi'an, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shiren Sun

Role: primary

Other Identifiers

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KY20222108-F-1

Identifier Type: -

Identifier Source: org_study_id

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