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Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial

Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063389
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Primary Membranous Nephropathy

Interventions

RT-R :Rituximab combined with tacrolimus induction + rituximab maintenance
RT-T:Rituximab combined with tacrolimus induction + tacrolimus maintenance
PC-C:Glucocorticoid combined with cyclophosphamide induction + maintenance

Sponsors

Renji Hospital Affiliated to Shanghai jiao tong university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. gender is not limited; 2. Age 18-75 3. Kidney biopsy pathology suggests primary membranous nephropathy; 4. Serological or histological PLA2R positive; 5. 24-hour urine protein quantification >= 3.5g/d and serum albumin = 45ml/min/1.73m2;

Exclusion criteria

Exclusion criteria: 1. Secondary membranous nephropathy (tumor-related, lupus-related, hepatitis B-related, infection-related, drug-related, etc.); 2. Renal biopsy pathology showed severe tubulointerstitial lesions; 3. Severe infection, severe cardiac insufficiency, severe hepatic insufficiency, gastrointestinal bleeding, ketoacidosis and other life-threatening complications within one month; 4. Glucocorticoids and/or immunosuppressive therapy (cyclophosphamide, MMF, tacrolimus) within 3 months; 5. have a history of kidney transplantation; 6. breastfeeding or pregnant women; 7. Patients with mental disorders or unable to cooperate ;

Design outcomes

Primary

MeasureTime frame
24h UTP;Scr;PLA2R;Alb;

Countries

China

Contacts

Public ContactQin Wang

Renji Hospital Affiliated to Shanghai jiao tong university school of medicine

qinwang_1975@126.com+86 13621964604

Outcome results

None listed

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