Authorised Therapeutic confirmatory (Phase III) Primary Membranous Nephropathy (pMN)

A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy

EU CTIS ID: 2023-506525-11-00

What this study is testing

To evaluate the efficacy of obinutuzumab compared with tacrolimus on the basis of the proportion of patients who achieve a complete remission (CR) at Week 104

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Ability to comply with the study protocol, in the investigator's judgment
  • Diagnosis of pMN according to renal biopsy prior to or during screening
  • Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
  • eGFR >= 40 mL/min/1.73m2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m2 based on 24-hour urine collection during screening
  • Patients who previously responded to calcineurin inhibitor (CNIs), rituximab, or alkylating agents with either a CR or partial remission and subsequently relapsed are eligible but require discontinuation of CNIs or alkylating agents for >= 6 months and rituximab for >= 9 months prior to screening
  • For patients enrolled in the extended China enrollment phase at China’s sites: current resident of mainland China and of Chinese ancestry

You likely can't join if

  • Uncontrolled blood pressure, in the opinion of the investigator, during 3 months prior to screening
  • Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
  • Receipt of renal replacement therapy
  • Type 1 or 2 diabetes mellitus
  • Receipt of previous therapies as follows: - Treatment with MMF or oral, intramuscular, or intravenous corticosteroids within 1 month prior to or during screening - Any B-cell depleting therapy such as rituximab, ocrelizumab, or ofatumumab within 9 months prior to or during screening - Treatment with cyclophosphamide or CNI within 6 months prior to or during screening - Treatment with any biologic therapy such as belimumab, ustekinumab, or anifrolumab within 6 months prior to or during screening - Treatment with an inhibitor of Janus-associated kinase, Bruton’s tyrosine kinase, or tyrosine kinase 2, including but not limited to tofacitinib, baricitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib within 3 months prior to or during screening - Treatment with any investigational agent within 28 days of screening or 5 drug-elimination half-lives of the investigational drug, whichever is longer - Receipt of a live vaccine within 28 days prior to screening or during screening
  • Patients with a secondary cause of MN (e.g., hepatitis B, SLE, medications, malignancies)

The study team makes the final eligibility decision.

Where it's taking place

  • Argentina
  • Israel
  • United States
  • Brazil
  • Ukraine
  • China
  • Peru
  • Russian Federation
  • Turkey

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; Israel; United States; Brazil; Ukraine; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.