Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04629248

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Primary Membranous Nephropathy

Interventions: Obinutuzumab, Tacrolimus, Methylprednisolone, Acetaminophen, Diphenhydramine

Countries: United States, Argentina, Brazil, China, France, Israel, Italy, Poland

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (50)
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Altamonte Springs, Florida, United States
  • Iowa City, Iowa, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Dallas, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Salvador, Estado de Bahia, Brazil
  • São José do Rio Preto, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Hangzhou, Zhejiang, China
  • Beijing, China
  • Chengdu, China
  • Fuzhou, China
  • Guangzhou, China
  • Shanghai, China
  • Shanghai, China
  • Wuhan, China
  • Xi'an, China
  • Yinchuan, China
  • Créteil, France
  • Paris, France
  • Toulouse, France
  • Ramat Gan, Israel
  • Bari, Apulia, Italy
  • + 20 more on CT.gov