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NCT03380962 · ClinicalTrials.gov registry record · Phase 1
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
A Phase 1 study of End Stage Renal Disease and Kidney Failure, Chronic, sponsored by Stanley Jordan, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03380962: Active Phase 1 study of End Stage Renal Disease and Kidney Failure, Chronic, sponsored by Stanley Jordan, MD.
NCT03380962 is a Phase 1 study of End Stage Renal Disease and Kidney Failure, Chronic that is active but no longer recruiting, run by Stanley Jordan, MD. The registered enrollment target is 20 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03380962, a Phase 1 study of End Stage Renal Disease and Kidney Failure, Chronic, is active but no longer recruiting, sponsored by Stanley Jordan, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.
Primary Outcome
Assessment of HLA antibodies from baseline based on luminex assessments at multiple time points
Conditions Studied
Interventions
- DRUG Clazakizumab
Study Locations (1)
California
- Norko Ammerman - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2025-08-30 |
| Phase | Phase 1 |
What the registry record for NCT03380962 still lists
NCT03380962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Clazakizumab is the first listed.
NCT03380962 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03380962 about?
NCT03380962 is a clinical study titled "Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant". Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm explor...
What is the current status of trial NCT03380962?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-02-27. Estimated completion is 2025-08-30.
What conditions does trial NCT03380962 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Failure, Chronic, Kidney Transplant; Complications, Transplant;Failure,Kidney, Antibody-mediated Rejection.
What interventions are being tested in trial NCT03380962?
The interventions under investigation include: Clazakizumab (DRUG).
Who is sponsoring clinical trial NCT03380962?
This trial is sponsored by Stanley Jordan, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03380962 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End Stage Renal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03380962's enrollment target sits among peer trials
20 69th of 86 higher than 17 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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