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NCT03284242 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
A Early Phase 1 study of End Stage Renal Disease and Kidney Transplant, sponsored by Roberto Gedaly.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03284242: Completed Early Phase 1 study of End Stage Renal Disease and Kidney Transplant, sponsored by Roberto Gedaly.
NCT03284242 is a Early Phase 1 study of End Stage Renal Disease and Kidney Transplant that has completed, run by Roberto Gedaly. The registered enrollment target is 9 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03284242, a Early Phase 1 study of End Stage Renal Disease and Kidney Transplant, has completed, sponsored by Roberto Gedaly.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy. Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.
Primary Outcome
Laboratory measurement and observed toxicities immediately and with in 24 hours post infusion of Tregs.
Conditions Studied
Interventions
- DRUG Treg
Study Locations (1)
Kentucky
- University of Kentucky Medical Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2024-04-10 |
| Phase | Early Phase 1 |
What the finished NCT03284242 record still lists
NCT03284242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Treg is the first listed.
NCT03284242 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03284242 about?
NCT03284242 is a clinical study titled "A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients". This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg ...
What is the current status of trial NCT03284242?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2019-03-15. Estimated completion is 2024-04-10.
What conditions does trial NCT03284242 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Transplant.
What interventions are being tested in trial NCT03284242?
The interventions under investigation include: Treg (DRUG).
Who is sponsoring clinical trial NCT03284242?
This trial is sponsored by Roberto Gedaly, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03284242 being conducted?
This trial has 1 study location across Kentucky. 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 NCT03284242's enrollment target sits among peer trials
9 81st of 86 higher than 6 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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