NCT02586051

A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation

Completed Phase 1 Last updated 29 January 2020

What this trial tests

Phase 1 trial testing Obinutuzumab in Kidney Failure, Chronic in 24 participants. Completed in 26 November 2018.

Timeline

19 November 2015

Primary endpoint
26 November 2018

26 November 2018

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	19 November 2015
Primary completion	26 November 2018
Estimated completion	26 November 2018
Sites	9 locations across United States

Drugs / interventions tested

• Obinutuzumab — full drug profile →
• Intravenous Immunoglobulin — full drug profile →

Conditions studied

• Kidney Failure, Chronic — all drugs for Kidney Failure, Chronic →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 65, any sex, with Kidney Failure, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obinutuzumab induces superior B-cell cytotoxicity to rituximab in rheumatoid arthritis and systemic lupus erythematosus patient samples.
   Reddy V, Klein C, Isenberg DA, Glennie MJ, et al · · 2017 · cited 134× · PMID 28407142 · DOI 10.1093/rheumatology/kex067
2. Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant.
   Redfield RR, Jordan SC, Busque S, Vincenti F, et al · · 2019 · cited 57× · PMID 31257724 · DOI 10.1111/ajt.15514
3. Obinutuzumab Effectively Depletes Key B-cell Subsets in Blood and Tissue in End-stage Renal Disease Patients.
   Looney CM, Schroeder A, Tavares E, Garg J, et al · · 2023 · cited 12× · PMID 36700064 · DOI 10.1097/txd.0000000000001436
4. New Therapies for Highly Sensitized Patients on the Waiting List.
   Vo A, Ammerman N, Jordan SC. · · 2024 · cited 9× · PMID 38995690 · DOI 10.34067/kid.0000000000000509
5. Novel insights in the clinical management of hyperimmune patients before and after transplantation.
   Grimaldi V, Pagano M, Moccia G, Maiello C, et al · · 2023 · cited 7× · PMID 36714552 · DOI 10.1016/j.crimmu.2023.100056
6. Obinutuzumab in kidney transplantation: Past, present, and future.
   Favi E, Morabito M. · · 2025 · PMID 41357414 · DOI 10.5500/wjt.v15.i4.108982