Back to resultsEfficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Primary Purpose
Glomerulonephritis, IGA
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prednisolone
Prednisolone plus Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, IGA
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CS
CS+CTX
Arm Description
low-dose corticosteroids monotherapy
low-dose corticosteroids combined with cyclophosphamide
Outcomes
Primary Outcome Measures
Combined event
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
Proteinuria remission
Hematuria remission at 6, 12 months and total follow-up period
Hematuria remission
The composite of 30% decrease in eGFR, ESRD and all cause death
The composite of 40% decrease in eGFR, ESRD and all cause death
The composite of 50% decrease in eGFR, ESRD and all cause death
Annual eGFR decline rate
30% decrease in eGFR
40% decrease in eGFR
50% decrease in eGFR
ESRD
All cause death
Full Information
NCT ID
NCT05510323
First Posted
August 18, 2022
Last Updated
August 19, 2022
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT05510323
Brief Title
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Official Title
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CS
Arm Type
Active Comparator
Arm Description
low-dose corticosteroids monotherapy
Arm Title
CS+CTX
Arm Type
Active Comparator
Arm Description
low-dose corticosteroids combined with cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
RAS blockade as much as tolerated or allowed
Intervention Type
Drug
Intervention Name(s)
Prednisolone plus Cyclophosphamide
Intervention Description
RAS blockade as much as tolerated or allowed
Primary Outcome Measure Information:
Title
Combined event
Description
40% decrease in eGFR, ESRD or death due to kidney disease
Time Frame
up to 6 years
Secondary Outcome Measure Information:
Title
Proteinuria remission at 6, 12 months and total follow-up period
Description
Proteinuria remission
Time Frame
up to 6 years
Title
Hematuria remission at 6, 12 months and total follow-up period
Description
Hematuria remission
Time Frame
up to 6 years
Title
The composite of 30% decrease in eGFR, ESRD and all cause death
Time Frame
up to 6 years
Title
The composite of 40% decrease in eGFR, ESRD and all cause death
Time Frame
up to 6 years
Title
The composite of 50% decrease in eGFR, ESRD and all cause death
Time Frame
up to 6 years
Title
Annual eGFR decline rate
Time Frame
up to 6 years
Title
30% decrease in eGFR
Time Frame
up to 6 years
Title
40% decrease in eGFR
Time Frame
up to 6 years
Title
50% decrease in eGFR
Time Frame
up to 6 years
Title
ESRD
Time Frame
up to 6 years
Title
All cause death
Time Frame
up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
We'll reach out to this number within 24 hrs