A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

  • STATUS
    Recruiting
  • End date
    Jun 1, 2028
  • participants needed
    140
  • sponsor
    Hoffmann-La Roche
Updated on 6 September 2021
Investigator
Reference Study ID Number: WA41937 http://www.roche.com/about_roche/roche_worldwide.htm
Primary Contact
Hospital Alberto Sabogal Sologuren (2.9 mi away) Contact
+79 other location

Summary

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

Details
Condition Primary Membranous Nephropathy
Treatment Tacrolimus, Methylprednisolone, Obinutuzumab, Acetaminophen, Diphenhydramine
Clinical Study IdentifierNCT04629248
SponsorHoffmann-La Roche
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
Urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection despite best supportive care for >= 3 months prior to screening or UPCR >= 4 g/g despite best supportive care >= 6 months prior to screening
eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
Other inclusion criteria may apply

Exclusion Criteria

Participants with a secondary cause of MN
Pregnancy or breastfeeding
Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
Severe renal impairment, including the need for dialysis or renal replacement therapy
Type 1 or 2 diabetes mellitus
Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening
Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
Known active infection of any kind or recent major episode of infection
Major surgery requiring hospitalization within the 4 weeks prior to screening
Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
Intolerance or contraindication to study therapies
Other exclusion criteria may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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