A randomized controlled trial for hydroxychloroquine sulfate in the treatment of idiopathic membranous nephropathy

The efficacy and safety of hydroxychloroquine sulfate in idiopathic membranous nephropathy: A randomized, controlled, Single-center clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021757

Enrollment

Unknown

Registered

2019-03-08

Start date

2019-03-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

Idiopathic Membranous Nephropathy

Interventions

Group 1:Supportive treatment+Perindopril 8 mg/day

Group 2:Supportive treatment+Perindopril 8 mg/day+hydroxychloroquine sulfate (200mg 2/d)

Group 3:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)

Group 4:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)+hydroxychloroquine sulfate (200mg 2/d)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary participation and written informed consent; (2) Gender is not limited, age is 18-60 years old; (3) Subjects should be diagnosed as idiopathic membranous nephropathy according to the following conditions: renal biopsy confirmed membranous nephropathy; PLA2R antibody positive; (4) Quantitative urinary protein (24h)> 500 mg/d; (5) Glomerular filtration rate (GFR) was > 45 mL/min/1.73 m2; (6) Abide by the research or follow-up procedure.

Exclusion criteria

Exclusion criteria: (1) Women who have recently had family planning, pregnancy or breastfeeding; (2) Failure to understand the potential risks and benefits of the study and follow-up assessment as required; (3) No capacity for civil conduct; (4) History of drug or alcohol abuse; (5) Active infections; (6) Patients with diabetic nephropathy, immune diseases, connective tissue diseases and amyloidosis may affect the study; (7) Any more complex medical problems may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, heart diseases, liver diseases, AIDS, viral hepatitis, etc.; (8) Fundus screening for ocular diseases is not suitable for the use of hydroxychloroquine sulfate.

Design outcomes

Primary

Measure	Time frame
Complete remission rate;	—

Secondary

Measure	Time frame
serum PLA2R;	—

Countries

China

Contacts

Public ContactBingbing Shen

Nephrology Division, First Hospital Affiliated to Army Medical University

sbbiceme1234@sina.com+86 18696550155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026