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

Glomerulonephritis, IGA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510323
• Other study ID #: KY20222108-F-1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2024
• Est. completion date: August 2028

Study information

• Verified date: May 2024
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: August 2028
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA

Intervention

Drug:
• Prednisolone
RAS blockade as much as tolerated or allowed
• Prednisolone plus Cyclophosphamide
RAS blockade as much as tolerated or allowed

Locations

Country	Name	City	State
China	AFMMU	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined event	40% decrease in eGFR, ESRD or death due to kidney disease	up to 6 years
Secondary	Proteinuria remission at 6, 12 months and total follow-up period	Proteinuria remission	up to 6 years
Secondary	Hematuria remission at 6, 12 months and total follow-up period	Hematuria remission	up to 6 years
Secondary	The composite of 30% decrease in eGFR, ESRD and all cause death		up to 6 years
Secondary	The composite of 40% decrease in eGFR, ESRD and all cause death		up to 6 years
Secondary	The composite of 50% decrease in eGFR, ESRD and all cause death		up to 6 years
Secondary	Annual eGFR decline rate		up to 6 years
Secondary	30% decrease in eGFR		up to 6 years
Secondary	40% decrease in eGFR		up to 6 years
Secondary	50% decrease in eGFR		up to 6 years
Secondary	ESRD		up to 6 years
Secondary	All cause death		up to 6 years