NCT05914155Active, not recruitingPhase 3
The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome （PRIME Study）
Shoichi Maruyama MD PhD18 sites in 1 country88 target enrollmentStarted: June 24, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 18
- Primary Endpoint
- Percentage of patients achieving ICR I
Study Overview
Brief Summary
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent
- •Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent and receive no steroids or immunosuppressants within 12 weeks prior to the obtainment of informed consent
- •Patients with urine protein-creatinine ratio ≥ 3.5 g/gCr at the screening
- •Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
- •Patients aged 15 years or older at informed consent
- •Patients who give voluntary written consent after having received adequate information on this study (legally acceptable representatives should also give consent for underage patients, and informed assent should be obtained from children)
Exclusion Criteria
- •Patients with primary nephrotic syndrome other than membranous nephropathy (IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis and so forth), and patients with secondary nephrotic syndrome (autoimmune disease, metabolic disease, infection, allergic/hypersensitive disease, tumor, and drug-induced disease)
- •Patients with the renal function lowered (eGFR <30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
- •Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous nephropathy
- •Patients who have participated in another clinical study within 12 weeks prior to the informed consent (enrollment is allowed for those participating in a clinical study in the range of 'Indications' or 'Dosage and Administration' in Japan) or patients who are participating in another study
- •Patients with history of renal transplant
- •Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
- •Patients who have or are suspected to have active infection (infection requiring treatment with systemic antimicrobial, antifungal, or antiviral agents) at the time of informed consent
- •Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody (patients with positive HBs antibody and/or HBc antibody can be enrolled only when HBV-DNA test is negative [less than the detection limit]), or patients with positive HIV antibody or HTLV-1 antibody at the time of the screening
- •Patients with leukopenia (less than 2,000 /mm3), neutropenia (less than 1,000 /mm3), or lymphopenia (less than 500 /mm3) at the time of the screening
- •Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
- •Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
- •Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
- •Female patients who are pregnant, lactating, or potentially pregnant, patients who are not willing to use contraceptive measures during the study period, or female patients not willing to use contraceptive measures until 12 months after the last dose of study drug (except for female patients who are unale to pregnant)
- •Patients who are judged to be unsuitable by the investigator or a subinvestigator
Arms & Interventions
Placebo group in double-blind phase
Placebo Comparator
Intervention: Placebo (Drug)
Rituximab group in double-blind phase
Active Comparator
Intervention: Rituximab (genetical recombination) (Drug)
Rituximab group in open-label phase
Other
Intervention: Rituximab (genetical recombination) (Drug)
Outcomes
Primary Outcomes
Percentage of patients achieving ICR I
Time Frame: up to 26 weeks
Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".
Secondary Outcomes
- Expression of HACA(up to 26 weeks)
- Serum rituximab (genetical recombination) concentration(up to 26 weeks)
- B-cells (CD19-positive and CD20-positive cells)(up to 26 weeks)
- Percentage of patients who are CR, ICR I, ICR II, NR or PR(up to 26 weeks)
- Duration before achieving CR, ICR I, ICR II or PR(up to 26 weeks)
- eGFR(up to 26 weeks)
- Urine protein-creatinine ratio(up to 26 weeks)
Investigators
Shoichi Maruyama MD PhD
Professor
Nagoya University
Study Sites (18)
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