Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Rituximab (genetical recombination)

    Drug

    Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.

  • Placebo

    Drug

    Administer placebo IV infusion every two weeks for two doses in double-blind phase.

  • Rituximab (genetical recombination)

    Drug

    Patients who remain to be ICR II (Incomplete Remission Type II) or NR (No Response) until Week 26 in the double-blind phase, if the patients wish to move to the open-label phase and the investigator or a subinvestigator considers the move necessary, the patient will move to the open-label phase and receive 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses after the readministration criteria are confirmed to be met.

Treatment groups

88 Participants
are divided into 3 treatment groups
Group A: Rituximab group in double-blind phaseActive comparator 1 intervention
Group B: Placebo group in double-blind phasePlacebo comparator 1 intervention
Group C: Rituximab group in open-label phaseOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients achieving ICR I

Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".

Time frame
up to 26 weeks

Secondary outcomes

1

Percentage of patients who are CR, ICR I, ICR II, NR or PR

CR, ICR I, ICR II, NR or PR are defied as below; CR (Complete Remission): Urine protein-creatinine ratio \< 0.3 g/gCr ICR I (Incomplete Remission Type I): 0.3 g/gCr ≤ Urine protein-creatinine ratio \< 1.0 g/gCr ICR II (Incomplete Remission Type II): 1.0 g/gCr ≤ Urine protein-creatinine ratio \< 3.5 g/gCr NR (No Response): 3.5 g/gCr ≤ Urine protein-creatinine ratio PR (Partial Remission): Decrease in urine protein-creatinine ratio from base line ≥50%, and urine protein-creatinine ratio 0.3 to 3.5 g/gCr

Time frame
up to 26 weeks
2

Duration before achieving CR, ICR I, ICR II or PR

Duration of achieving CR, ICR I, ICR II or PR is summarized.

Time frame
up to 26 weeks
3

Urine protein-creatinine ratio

The differences of urine protein-creatinine ratio between prior to treatment and at each timepoint are summarized.

Time frame
up to 26 weeks
4

eGFR

The differences of eGFR between prior to treatment and at each timepoint are summarized.

Time frame
up to 26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shoichi Maruyama MD PhD

Lead sponsor

Nagoya University

Sponsor institution

Source ClinicalTrials.gov
Apply now