Health Trials

Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome

ConditionsGlomerulonephritis, MembranousNephrotic Syndrome，Idiopathic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorShoichi Maruyama MD PhD

About this trial

To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Rituximab (genetical recombination)
  • Placebo
  • Rituximab (genetical recombination)

Treatment groups

88 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shoichi Maruyama MD PhD

Lead sponsor

Nagoya University

Sponsor institution

Source ClinicalTrials.gov