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NCT01336296 · ClinicalTrials.gov registry record · Phase 4
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
A Phase 4 study of Kidney Transplant Recipients, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT01336296: Completed Phase 4 study of Kidney Transplant Recipients, sponsored by University of Cincinnati.
NCT01336296 is a Phase 4 study of Kidney Transplant Recipients that has completed, run by University of Cincinnati. The registered enrollment target is 61 participants, roughly in line with the 63-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01336296, a Phase 4 study of Kidney Transplant Recipients, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.
Primary Outcome
Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: As with humoral rejection, there are both acute \& chronic forms: The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: Class IA: there is
Conditions Studied
Interventions
- DRUG mycophenolic acid
Study Locations (1)
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01336296 record still lists
NCT01336296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 63-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target.
The record links to 1 condition, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 1 intervention - of which mycophenolic acid is the first listed.
NCT01336296 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01336296 about?
NCT01336296 is a clinical study titled "Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients". This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will b...
What is the current status of trial NCT01336296?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2010-09. Estimated completion is 2014-04.
What conditions does trial NCT01336296 study?
This clinical trial studies the following conditions: Kidney Transplant Recipients.
What interventions are being tested in trial NCT01336296?
The interventions under investigation include: mycophenolic acid (DRUG).
Who is sponsoring clinical trial NCT01336296?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01336296 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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