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NCT05017545 · ClinicalTrials.gov registry record · Phase 1
Carfilzomib and Belatacept for Desensitization
A Phase 1 study of Highly Sensitized Prospective Kidney Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05017545: Active Phase 1 study of Highly Sensitized Prospective Kidney Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05017545 is a Phase 1 study of Highly Sensitized Prospective Kidney Transplant Recipients that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05017545, a Phase 1 study of Highly Sensitized Prospective Kidney Transplant Recipients, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die while on the kidney transplant waitlist. The purpose of this study is to find out whether two drugs, carfilzomib (Kyprolis®),and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
Primary Outcome
Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 26 post treatment initiation or until receiving a transplant, whichever occurs earlier: 1. Grade 3 or higher infusion reaction, 2. Grade 3 or higher infections, and 3. Any malignancy. The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Ad
Conditions Studied
Interventions
- BIOLOGICAL carfilzomib
- BIOLOGICAL belatacept
- PROCEDURE Bone marrow aspiration
Study Locations (1)
North Carolina
- Duke Transplant Center, Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-12-28 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 1 |
What the registry record for NCT05017545 still lists
NCT05017545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Highly Sensitized Prospective Kidney Transplant Recipients appearing as the primary indexed condition, and to 3 interventions - of which carfilzomib is the first listed.
NCT05017545 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05017545 about?
NCT05017545 is a clinical study titled "Carfilzomib and Belatacept for Desensitization". Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found f...
What is the current status of trial NCT05017545?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-12-28. Estimated completion is 2028-02-28.
What conditions does trial NCT05017545 study?
This clinical trial studies the following conditions: Highly Sensitized Prospective Kidney Transplant Recipients.
What interventions are being tested in trial NCT05017545?
The interventions under investigation include: carfilzomib (BIOLOGICAL), belatacept (BIOLOGICAL), Bone marrow aspiration (PROCEDURE).
Who is sponsoring clinical trial NCT05017545?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05017545 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05017545's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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