Status:
NOT_YET_RECRUITING
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Primary Membranous Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. Eighty-eight patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention...
Detailed Description
After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio in a double-blinded manner. The interventio...
Eligibility Criteria
Inclusion
- Adults (age≥18,and ≤75) with primary MN.
- Administration of the maximum tolerable dose of ACEI/ARB for ≥4 weeks.
- BP ≤140/90 mmHg.
- Urine protein content of 1.0-5.0 g/d.
- eGFR ≥60 (CKD-EPI).
- Postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women.
- Voluntary signing of informed consent.
Exclusion
- Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.
- Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).
- Uncontrolled arterial hypertension.
- Treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months.
- Treatment with any other study drug within the last month.
- Females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. Female or male patients unwilling to use contraceptive methods throughout the study.
- A history of mental illness.
- Laboratory tests meeting the following criteria:
- Hemoglobin levels \<80 g/L;
- Platelet count \<80×109/L;
- Neutrophil count \<1.0×109/L;
- Aspartate aminotransferase (AST) or amino aminotransferase (ALT) \>2.5 times the upper limit of normal, except in relation to the primary disease.
- Very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function).
- Unsuitability for inclusion in the trial as judged by the investigator.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06573411
Start Date
September 30 2024
End Date
October 30 2025
Last Update
August 27 2024
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