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NCT02586051 · ClinicalTrials.gov registry record · Phase 1
A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation
A Phase 1 study of Kidney Failure, Chronic, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 9
- Study locations
NCT02586051 is a Phase 1 study of Kidney Failure, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 5 states.
The verdict
NCT02586051, a Phase 1 study of Kidney Failure, Chronic, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 9
- Study locations
Study 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). 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.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Intravenous Immunoglobulin
Study Locations (9)
California
- Cedars-Sinai Medical Center - Los Angeles
- UCSF - San Francisco
- Stanford Health Care - Stanford
Minnesota
- Mayo Clinic - Minnesota - Rochester
- Mayo Clinic - Rochester
Ohio
- The Christ Hospital - Cincinnati
- University of Cincinnati College of Medicine - Cincinnati
Maryland
- Johns Hopkins Hospital - Baltimore
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2018-11-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02586051
The ClinicalTrials.gov registry entry for NCT02586051 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (93% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT02586051 reports 9 study locations spanning 5 distinct geographic areas - top geographies include California, Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT02586051 about?
NCT02586051 is a clinical study titled "A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting 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. Bo...
What is the current status of trial NCT02586051?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-11-19. Estimated completion is 2018-11-26.
What conditions does trial NCT02586051 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic.
What interventions are being tested in trial NCT02586051?
The interventions under investigation include: Obinutuzumab (DRUG), Intravenous Immunoglobulin (DRUG).
Who is sponsoring clinical trial NCT02586051?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02586051 being conducted?
This trial has 9 study locations across California, Maryland, Minnesota, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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