Skip to main content
Eligibility
for people ages 18 years to 65 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2) obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk of infusion-related reactions (IRRs). In Cohort 1, 5 participants will receive single dose obinutuzumab IV infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post dose for the last participant of cohort 1, cohort 2 will be allowed to proceed. In Cohort 2, 20 participants will receive obinutuzumab IV infusion on Days 1 and 15. Participants who qualify for transplantation and receive a compatible kidney offer after inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the desensitization phase and at Week 28 post-transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion.

Official Title

A Phase Ib, Single- and Multiple-Dose, Open-Label Study of The Safety, Pharmacokinetics and Pharmacodynamics of Obinutuzumab in Adults With End-Stage Renal Disease and Hypersensitization Awaiting Renal Transplantation

Keywords

Kidney Failure, Chronic Obinutuzumab

Eligibility

You can join if…

Open to people ages 18 years to 65 years

  • ESRD with a history of sensitizing events
  • United network for organ sharing (UNOS)-listed with at least one match run for a deceased donor kidney during the past year
  • Adult participants with 18 to 65 years of age
  • Female participants of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception during the treatment period and for at least 18 months after the last dose of study drug
  • Male participants: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 12 months after the last dose of study drug

You CAN'T join if...

  • Incomplete recovery from recent major surgery or less than (<) 12 weeks since major surgery prior to baseline and participants planned surgery within 24 weeks of baseline except for kidney transplantation
  • Pregnant or lactating women
  • Positive serum human chorionic gonadotropin (hCG) measured prior to the first obinutuzumab infusion
  • Primary or secondary immunodeficiency disease
  • Seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody(HBcAb) or seropositivity for Hepatitis C
  • History of active or latent tuberculosis (TB) or suspicion of active TB
  • Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse
  • Participants who received more than one organ transplant
  • Participants for synchronous organ transplant
  • Recipients of any live attenuated vaccine(s) within 1 month of the screening visit
  • Abnormal screening laboratory results
  • Participants with a history of major cardiovascular or pulmonary disease
  • Use of investigational agents within 12 weeks or five half-lives of randomization
  • Use of an anti-CD20 therapy within the past 12 months
  • Known contraindications to obinutuzumab
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or components of obinutuzumab infusion
  • Participants with ESRD on peritoneal dialysis

Locations

  • San Francisco, California, 94115, USA
  • Stanford, California, 94305, USA
  • Los Angeles, California, 90048, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02586051
Phase
Phase 1
Lead Scientist
Flavio Vincenti
Study Type
Interventional
Last Updated
November 2016