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NCT03726307 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study
A Phase 1 study of Kidney Transplant and Renal Transplant Recipients, sponsored by Angus W. Thomson PhD DSc.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03726307: Active Phase 1 study of Kidney Transplant and Renal Transplant Recipients, sponsored by Angus W. Thomson PhD DSc.
NCT03726307 is a Phase 1 study of Kidney Transplant and Renal Transplant Recipients that is active but no longer recruiting, run by Angus W. Thomson PhD DSc. The registered enrollment target is 28 participants, below the 1,897-participant average among 30 other Kidney Transplant 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
NCT03726307, a Phase 1 study of Kidney Transplant and Renal Transplant Recipients, is active but no longer recruiting, sponsored by Angus W. Thomson PhD DSc.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients. DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. This study will enroll 28 subjects (14 recipients, 14 donors). The duration of follow-up will be: * 1 week following the leukapheresis procedure for donors and * 2 years following their DCreg infusion for kidney recipients.
Primary Outcome
Safety will be assessed by summarizing the proportion of participants who experience any of the following events from the initiation of the regulatory dendritic cells (DCreg) infusion administered 7 days prior to kidney transplant to 1 year post-transplant: * Recipient death attributed to receipt of DCreg, * NCI-CTCAE Grade 4 or higher DCreg infusion reaction, * NCI-CTCAE Grade 4 or higher infection, * Malignancy other than non-melanoma skin cancer, * Pre-transplant Donor Specific Antibodies (D
Conditions Studied
Interventions
- BIOLOGICAL DCreg: 0.5 million cells/kg+SOC
- BIOLOGICAL DCreg: 1.2 million cells/kg+SOC
- BIOLOGICAL DCreg:2.5 to 5.0 million cells/kg+SOC
Study Locations (1)
Pennsylvania
- University of Pittsburgh, Starzl Transplantation Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What the registry record for NCT03726307 still lists
NCT03726307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Kidney Transplant appearing as the primary indexed condition, and to 3 interventions - of which DCreg: 0.5 million cells/kg+SOC is the first listed.
NCT03726307 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03726307 about?
NCT03726307 is a clinical study titled "Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study". This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients. DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) ...
What is the current status of trial NCT03726307?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-04-10. Estimated completion is 2027-03.
What conditions does trial NCT03726307 study?
This clinical trial studies the following conditions: Kidney Transplant, Renal Transplant Recipients.
What interventions are being tested in trial NCT03726307?
The interventions under investigation include: DCreg: 0.5 million cells/kg+SOC (BIOLOGICAL), DCreg: 1.2 million cells/kg+SOC (BIOLOGICAL), DCreg:2.5 to 5.0 million cells/kg+SOC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03726307?
This trial is sponsored by Angus W. Thomson PhD DSc, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03726307 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03726307's enrollment target sits among peer trials
28 22nd of 30 higher than 9 of 30 other Kidney Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant 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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