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NCT05325073 · ClinicalTrials.gov registry record · Phase 4
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
A Phase 4 study of Liver Transplant Rejection, sponsored by Northwestern University.
- Active
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05325073: Active Phase 4 study of Liver Transplant Rejection, sponsored by Northwestern University.
NCT05325073 is a Phase 4 study of Liver Transplant Rejection that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 9 participants, below the 52-participant average among 3 other Liver Transplant Rejection trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05325073, a Phase 4 study of Liver Transplant Rejection, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.
Primary Outcome
We will use flow cytometry to analyze the phenotype of peripheral blood mononuclear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lymphocyte subset frequencies, including Tregs
Conditions Studied
Interventions
- DRUG Erythropoietin
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 4 |
What the registry record for NCT05325073 still lists
NCT05325073 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 52-participant average among 3 other Liver Transplant Rejection trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Liver Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which Erythropoietin is the first listed.
NCT05325073 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05325073 about?
NCT05325073 is a clinical study titled "Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients". The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinic...
What is the current status of trial NCT05325073?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2022-02-18. Estimated completion is 2024-09-30.
What conditions does trial NCT05325073 study?
This clinical trial studies the following conditions: Liver Transplant Rejection.
What interventions are being tested in trial NCT05325073?
The interventions under investigation include: Erythropoietin (DRUG).
Who is sponsoring clinical trial NCT05325073?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05325073 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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