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NCT04827979 · ClinicalTrials.gov registry record · Phase 1
Daratumumab 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
- 19
- Enrollment target
- 1
- Study location
NCT04827979: Active Phase 1 study of Highly Sensitized Prospective Kidney Transplant Recipients, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04827979 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 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04827979, 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
- 19 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 on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), 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 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier: 1. Grade 3 or higher infusion reaction 2. Grade 3 or higher infections 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 Adverse E
Conditions Studied
Interventions
- BIOLOGICAL belatacept
- PROCEDURE Bone marrow aspiration
- BIOLOGICAL daratumumab
Study Locations (1)
California
- University of California at San Francisco Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
What the registry record for NCT04827979 still lists
NCT04827979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% 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 belatacept is the first listed.
NCT04827979 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04827979 about?
NCT04827979 is a clinical study titled "Daratumumab 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 NCT04827979?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2021-11-01. Estimated completion is 2028-04-30.
What conditions does trial NCT04827979 study?
This clinical trial studies the following conditions: Highly Sensitized Prospective Kidney Transplant Recipients.
What interventions are being tested in trial NCT04827979?
The interventions under investigation include: belatacept (BIOLOGICAL), Bone marrow aspiration (PROCEDURE), daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04827979?
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 NCT04827979 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
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Where NCT04827979's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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