Skip to content

A randomized controlled clinical study of hydroxychloroquine in the treatment of idiopathic membranous nephropathy

A randomized controlled clinical study of hydroxychloroquine in the treatment of idiopathic membranous nephropathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067000
Enrollment
Unknown
Registered
2022-12-23
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

idiopathic membranous nephropathy

Interventions

Treatment group:Hydroxychloroquine (HCQ)+tacrolimus (FK506)+hormone (P)
Control group:Placebo+tacrolimus (FK506)+hormone (P)

Sponsors

The Seventh Affiliated Hospital of Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age:18-65 years old, regardless of gender or nationality; 2) Idiopathic membranous nephropathy (IMN) was diagnosed by two renal pathologists who read the films and ruled out secondary membranous nephropathy (SMN); 3) The clinical evaluation requires hormone combined immunosuppressive therapy, including: Moderate risk patients, with normal eGFR, have received = 3 months of ACEI and/or ARB treatment, and their blood pressure is controlled (75% of the records), there are still proteinuria>4 g/d (confirmed twice) or urine protein decrease = 50%, and PLA2Rab8g/d = 3 months, PLA2Ra>50RU/ml; 4)eGFR>30ml.min.1.73m2 5) Sign the written consent.

Exclusion criteria

Exclusion criteria: 1) Unable or unwilling to sign written consent; 2) Secondary MN (such as hepatitis B, SLE, drugs, malignant tumors, etc.) 3) Type 1 or type 2 diabetes can not be differentiated from diabetes nephropathy 4) Blood creatinine > 4mg/dl (353umol/L); 5) Pregnancy, lactation or contraception by unreliable means; 6) Before randomization, maintenance dialysis was>2 weeks and/or maintenance dialysis was expected to be>8 weeks; 7) Kidney transplantation or planned kidney transplantation; 8) Allergies or contraindications to planned drugs 9) Patients with psoriasis or porphyria; 10) Retinopathy; 11) Participated in other clinical trials and/or used the study drug within 4 weeks before screening.

Design outcomes

Primary

MeasureTime frame
complete remission rate;Partial remission rate;

Countries

China

Contacts

Public Contactzheng,zhihua

The Seventh Affiliated Hospital of Sun Yat sen University

zhzhihua@mail.sysu.edu.cn13922298682

Outcome results

None listed

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