Actively Recruiting
Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-04-02
78
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by \> 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.
CONDITIONS
Official Title
Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18-75 years
- Diagnosed with primary membranous nephropathy by kidney biopsy
- Treated with ACE inhibitors or ARBs for at least 3 months unless not suitable
- Average 24-hour urine protein ≥3.5g twice a week, or ≥5g twice in 14 days (if treated with ACE inhibitors or ARBs)
- Blood pressure ≤130/80 mmHg
- Glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2
- If female, postmenopausal, surgically infertile, or using medical contraception
- Voluntarily signed informed consent form
You will not qualify if you...
- Type 1 or type 2 diabetes with diabetic nephropathy, except recent steroid-induced diabetes without secondary nephropathy
- Secondary membranous nephropathy due to known causes like hepatitis B or C, lupus, drugs, cancer
- Prior treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate, or azathioprine
- Use of any other study medication within the last month
- Known allergy or immune reaction to rituximab, corticosteroids, or their components
- Active infections including hepatitis B or C, tuberculosis within 1 year, or HIV infection
- History of immunodeficiency or organ transplantation
- Positive pregnancy test, lactating, or planning pregnancy within 24 months; unwillingness to use contraception
- History of mental illness
- Laboratory abnormalities: hemoglobin <80 g/L, platelet <80×10⁹/L, neutrophil <1.0×10⁹/L, elevated liver enzymes >2.5× upper limit without relation to primary disease
- Life-threatening nephrotic syndrome or rapid unexplained decline in kidney function
- Any condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wei Chen
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wei Chen
CONTACT
Q
Qiong Wen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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