Kidney Failure, Chronic Clinical Trial
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
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).
Desensitization Period: In Cohort 1, 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,
participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period:
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.
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