Glomerulonephritis, MembranousPhase 3PRIMENCT05914155
Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome
A Phase 3 study testing Rituximab (genetical recombination) in people with Glomerulonephritis, Membranous and Nephrotic Syndrome，Idiopathic, run by Shoichi Maruyama MD PhD at 18 sites in Japan.
Trial summary
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Glomerulonephritis, Membranous, Nephrotic Syndrome，Idiopathic
- What is being tested?
- Rituximab (genetical recombination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 18 sitesJapan
- Study dates
- 24 Jun 2023to 30 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Anjo Kosei Hospital
Anjo, Aichi-ken, 4468602
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 0788510
Kyushu University Hospital
Fukuoka, Fukuoka, 8128582
Hamamatsu University Hosptial
Hamamatsu, Shizuoka, 4313129
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 9208641
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
Konan Kosei Hospital
Kōnan, Aichi-ken, 4838704
Kumamoto University Hospital
Kumamoto, Kumamoto, 8608556
Kurume University Hospial
Kurume, Fukuoka, 8300011
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 6028566
Kyoto University Hospital
Kyoto, Kyoto, 6068507
Nagoya University Hospital
Nagoya, Aichi-ken, 4668560
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Osaka, Osaka, 5308480
Osaka University Hospital
Osaka, Osaka, 5650871
Tohoku University Hospital
Sendai, Miyagi, 9808574
Fujita Health University hospital
Toyoake, Aichi-ken, 4701192
Mie University Hospial
Tsu, Mie-ken, 5148507
Juntendo University Urayasu Hospital
Urayasu, Chiba, 2790021
About this study
Official title: 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）
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
- Being tested
- Rituximab (genetical recombination), Placebo
- Medical subject headings
- Glomerulonephritis, Membranous, Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (genetical recombination)Drug
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab group in double-blind phase | Active comparator | Not described Receives: Drug: Rituximab (genetical recombination) |
| Placebo group in double-blind phase | Placebo comparator | Not described Receives: Drug: Placebo |
| Rituximab group in open-label phase | Other | Not described Receives: Drug: Rituximab (genetical recombination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving ICR I
Achieving ICR I is defined as "Urine protein-creatinine ratio < 1.0 g/gCr".
Measured: up to 26 weeks
Secondary outcomes (7)
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
Measured: up to 26 weeks
Duration before achieving CR, ICR I, ICR II or PR
Duration of achieving CR, ICR I, ICR II or PR is summarized.
Measured: up to 26 weeks
Urine protein-creatinine ratio
The differences of urine protein-creatinine ratio between prior to treatment and at each timepoint are summarized.
Measured: up to 26 weeks
eGFR
The differences of eGFR between prior to treatment and at each timepoint are summarized.
Measured: up to 26 weeks
B-cells (CD19-positive and CD20-positive cells)
B cell counts (CD19 positive and CD20 positive cell counts) at each timepoint are summarized.
Measured: up to 26 weeks
Expression of HACA
The number of patients expressing HACA, and the proportion of these patients at each timepoint are summarized.
Measured: up to 26 weeks
Serum rituximab (genetical recombination) concentration
Serum rituximab (genetical recombination) level at each timepoint are summarized.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Jun 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shoichi Maruyama MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shoichi Maruyama MD PhD, Nagoya University
- Investigators
- Shoichi Shoichi, PhD, MD, Principal investigator, Nagoya University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914155
- Sponsor's protocol ID
- CAMCR-020
- Acronym
- PRIME
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Shimizu S, Tanaka A, Matsuyama N, Kinoshita F, Furuhashi K, Maruyama S; PRIME Study Group. Randomised, double-blind study to evaluate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A clinical trial protocol. PLoS One. 2025 Mar 18;20(3):e0320070. doi: 10.1371/journal.pone.0320070. eCollection 2025.
PubMed 40100934Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
PubMed 39513526