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Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy

Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033540
Enrollment
Unknown
Registered
2020-06-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Membranous Nephropathy

Interventions

experimental group:Rituximab 600mg iv, and supportive treatment
control group:Supportive treatment according to KDIGO guideline

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following conditions will be introduced to this study: 1) age: 18 to 70 years old; 2) qualitative diagnosis: 24h urine protein more than 1 gram, anti-PLA2R antibody more than 50U/ml, and serum albumin more than 30g/L; 3) biopsy-proven or clinically diagnosed membranous nephropathy; 4) estimated GFR more than 30 ml/min; 5) patients and families are willing to participate in the study.

Exclusion criteria

Exclusion criteria: We exclude patients who have any of the following conditions: 1) tumor or expected survival period less than 6 months; 2) surgical procedure is needed recently; 3) pregnant or lactating women; 4) current bacterial infection; 5) latent tuberculosis, Hepatitis B or C virus infection, or any conditions infection physician consider not suitable for rituximab treatment; 6) active cytomegalovirus infection; 7) unexplained body temperature greater than 37.5 degrees celsius; 8) the researchers believe that there are other reasons not suitable for the clinical study.

Design outcomes

Primary

MeasureTime frame
24 hour urine protein;Serum albumin;Serum Creatinine;anti PLA2R antibody;Judgment of Nephrotic Syndrome;

Countries

China

Contacts

Public ContactGang Chen

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

chengang@pumch.cn+86 18600112886

Outcome results

None listed

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