The trial is taking place at:
P

Prolato Clinical Research Center | Houston, TX

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

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Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Primary Membranous Nephropathy

Treatments

Drug: Diphenhydramine
Drug: Acetaminophen
Drug: Tacrolimus
Drug: Methylprednisolone
Drug: Obinutuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04629248
2020-003233-38 (EudraCT Number)
2023-506525-11-00 (Other Identifier)
WA41937

Details and patient eligibility

About

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

Enrollment

140 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of primary membranous nephropathy (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/1.73m^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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Open Label Treatment: Obinutuzumab
Experimental group
Description:
Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA).
Treatment:
Drug: Obinutuzumab
Drug: Methylprednisolone
Drug: Acetaminophen
Drug: Diphenhydramine
Open Label Treatment: Tacrolimus
Active Comparator group
Description:
Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA).
Treatment:
Drug: Tacrolimus

Trial contacts and locations

56

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Central trial contact

Reference Study ID Number: WA41937 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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