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NCT03504241 · ClinicalTrials.gov registry record · Phase 1
Tolerance by Engaging Antigen During Cellular Homeostasis
A Phase 1 study of Kidney Transplantation and Renal Transplantation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03504241: Completed Phase 1 study of Kidney Transplantation and Renal Transplantation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03504241 is a Phase 1 study of Kidney Transplantation and Renal Transplantation that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants, below the 268-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504241, a Phase 1 study of Kidney Transplantation and Renal Transplantation, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine if: * it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and * the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".
Primary Outcome
Operational tolerance (to their kidney transplant) defined by participant remaining off all immunosuppression for 52 weeks after completion of Immunosuppression Withdrawal (ISW) with: * No evidence of biopsy-proven allograft rejection after initiation of ISW; * Acceptable renal function, defined as an estimated GFR \> 60 ml/min/1.73cm\^2 calculated using the CKD-EPI equation or a serum creatinine that has increased no more than 25% above baseline, as assessed at the week 52 visit after completi
Conditions Studied
Interventions
- DRUG sirolimus
- DRUG mycophenolate mofetil
- BIOLOGICAL Donor-derived Mesenchymal Stromal Cells
- DRUG alemtuzumab
- DRUG belatacept
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2025-09-16 |
| Phase | Phase 1 |
What the finished NCT03504241 record still lists
NCT03504241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 268-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which sirolimus is the first listed.
NCT03504241 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03504241 about?
NCT03504241 is a clinical study titled "Tolerance by Engaging Antigen During Cellular Homeostasis". Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this s...
What is the current status of trial NCT03504241?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-07-30. Estimated completion is 2025-09-16.
What conditions does trial NCT03504241 study?
This clinical trial studies the following conditions: Kidney Transplantation, Renal Transplantation, Renal Transplant Recipient.
What interventions are being tested in trial NCT03504241?
The interventions under investigation include: sirolimus (DRUG), mycophenolate mofetil (DRUG), Donor-derived Mesenchymal Stromal Cells (BIOLOGICAL), alemtuzumab (DRUG), belatacept (DRUG).
Who is sponsoring clinical trial NCT03504241?
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 NCT03504241 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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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 NCT03504241's enrollment target sits among peer trials
8 34th of 33 the lowest of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation 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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