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Efficacy and safety study of RASI combined with SGLT2I, finasteride and hydroxychloroquine in the treatment of idiopathic membranous nephropathy

Efficacy and safety study of RASI combined with SGLT2I, finasteride and hydroxychloroquine in the treatment of idiopathic membranous nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086359
Enrollment
Unknown
Registered
2024-06-29
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

membranous neohropathy

Interventions

RASI, finerenone and SGLT2I group:After receiving the maximum tolerated dose of ACEI/ARB for 4 weeks, the treatment was combined with finerenone and SGLT2i. The finerenone regimen was 10 mg orally, 1/
RASI, finerenone, SGLT2I and hydroxychloroquine group:After 4 weeks of ACEI/ARB treatment at the maximum tolerated dose, the treatment was combined with finerenone, SGLT2I and hydroxychloroquine
the finerenone regimen was 10 mg orally, 1/day for 26 weeks
the SGLT2i regimen was dapagliflozin 10 mg orally, 1/day for 26 weeks
and hydroxychloroquine regimen was 400 mg/day orally for 26 weeks in patients with a body weight of =50 kg and 300 mg/d orally in patients with a body weight of <50 kg for 26 weeks.

Sponsors

The First Affiliated Hospital of the People's Liberation Army Air Force University of Military Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent is obtained; 2. Aged 18-80 years; 3. Patients diagnosed with idiopathic membranous nephropathy by renal biopsy and not converted to urine protein after 3-6 months of previous hormonal and immunosuppressive therapy. 4. eGFR =30 ml/min .1.73 m2, urine protein 30 g/L; 5. Blood potassium = 5 mmol/L;

Exclusion criteria

Exclusion criteria: 1. Presence of active infection or diagnosis of secondary membranous nephropathy; 2. Positive HBV serology (HBsAg or/and HBeAg or HBcAb), HCV positivity or abnormal liver function; 3. Diagnosis of diabetes mellitus or impaired glucose tolerance (2-hour postprandial blood glucose 7.8-11 mmol/L). 4. Have a clear history of peptic ulcer and/or gastrointestinal bleeding within the last six months 5. Have a congenital or acquired immunodeficiency, or with active tuberculosis and active cytomegalovirus infection, or with a severe infectious defect requiring intravenous antibiotic therapy 6. Suffering from serious cardiovascular diseases such as congenital heart disease, cardiac arrhythmia and heart failure; 7. Other serious physical or mental illness; 8. Pregnancy, contraceptive failure, or breastfeeding; 9. Hormones and immunosuppressants have been applied in the three months prior to enrolment; 10. Participation in other clinical trials within three months prior to enrolment; 11. Blood pressure = 90/60 mmHg; 12. Those who are allergic to hydroxychloroquine; 13. Those with eye diseases; 14. Those with heart block;

Design outcomes

Primary

MeasureTime frame
Random urine protein/creatinine(UACR);24-hour urine protein quantification;

Secondary

MeasureTime frame
Serum Phospholipase A2 Receptor Antibody(PLA2Rab);glycosylated hemoglobin(HbA1c%);routine urinalysis;Estimating glomerular filtration rate;kidney function;haemonium;blood lipid;blood glucose;blood counts;serum albumin;

Countries

China

Contacts

Public ContactLijie He

The First Affiliated Hospital of the People's Liberation Army Air Force University of Military Medicine

chenye18821756225@163.com+86 150 9118 5737

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026