Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Study ID
- NCT06460987
- Status
- Completed
Conditions
- Finerenone
- IgA Nephropathy
- Proteinuria
- Safety Issues
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Finerenone — DRUGTaking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels
- RAS inhibitor — DRUGReceive RAS inhibitor treatment as specified in the KDIGO guidelines
- Immune Suppressant — DRUGReceive immune suppressant treatment as specified in the KDIGO guidelines
Study Details
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
Key Dates
- Start date
- Dec 1, 2022
- Status verified
- Jun 2024
- Primary completion
- Mar 31, 2024
- Completion
- Mar 31, 2024
Study Design
- Enrollment
- 245 participants (actual)
Arms
- Arm: A group: FINE+RASI group;Patients treated with RASI and finerenone
- Arm: B group: RASI group;Patients treated with RASI only
- Arm: C group: immune suppressive + FINE + RASI;Patients receiving immunosuppressive drugs and RASIs
- Arm: D group: immune suppressive + RASI;Patients receiving immunosuppressants, RASI and finerenone
Primary Outcome Measure
percentage change in PCR from baseline to 6 months [ Time Frame: 6 month ]
Related Studies
- Rituximab Plus Cyclosporine in Idiopathic Membranous NephropathyPHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Proteinuria in Pre and Post TransplantRecruiting · University of Miami · Miami, Florida
- E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in AdultsPHASE1 · Enrolling By Invitation · Hospital for Special Surgery, New York · New York, New York
- Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina