臨床研究等提出・公開システム

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

PRIME Study (PRIME Study)

Akihito Tanaka

Nagoya University Hospial

65 Tsurumai-cho, Showa-ku, Nagoya, Aich

tanaka17@med.nagoya-u.ac.jp

Shinobu Shimizu

Nagoya University Hospial

65 Tsurumai-cho, Showa-ku, Nagoya, Aich

+81-52-744-2942

prime-jimukyoku@med.nagoya-u.ac.jp

Recruiting

June. 19, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent (1)
2. Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent (1) and receive no steroids or immunosuppressants within 12 weeks prior to the obtainment of informed consent
3. Patients with urine protein-creatinine ratio 3.5 g/gCr or more at the screening (1)
4. Patients with hypoalbuminemia (serum albumin 3.0 g/dL or less) at the screening (1)
5. Patients aged 15 years or older at informed consent (1)
6. 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)

1. 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)
2. Patients with the renal function lowered (eGFR less than 30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening (1)
3. Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent (1) for idiopathic membranous nephropathy
4. Patients who have participated in another clinical study within 12 weeks prior to the informed consent (1) (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
5. Patients with history of renal transplant
6. Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
7. Patients who have or are suspected of having an active infection at the time of informed consent (1)
8. 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 (1)
9. 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 (1)
10. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
11. Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
12. Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
13. 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)
14. Patients who are judged to be unsuitable by the investigator or a subinvestigator

Both

Membranous nephropathy

Administer 1,000 mg of rituximab (genetical recombination) or placebo IV infusion every two weeks for two doses in double-blind phase.
However, for patients who remain to be ICR II or NR 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.

Glomerulonephritis, Membranous

Infusions, Intravenous

D015433

D007262

Percentage of patients achieving ICR I

1. Percentage of patients who are CR, ICR I, ICR II, NR or PR at each assessment time point.
2. Duration before achieving CR, ICR I, ICR II or PR
3. Urine protein-creatinine ratio
4. eGFR
5. B-cells (CD19-positive and CD20-positive cells)
6. Expression of human anti-chimeric antibodies
7. Serum rituximab concentration

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Yes

If the principal investigator, clinical trial office, main stakeholder conclude that secondary use of individual data obtained in this clinical trial is beneficial for additional analysis, the secondary use of data excluding personal information will be acceptable after publication of results.

none