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NCT01280617 · ClinicalTrials.gov registry record · NA
Low Dose Thymoglobin in Renal Transplant Patients
A NA study of Acute Renal Failure, sponsored by Lahey Clinic.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01280617: Completed NA study of Acute Renal Failure, sponsored by Lahey Clinic.
NCT01280617 is a NA study of Acute Renal Failure that has completed, run by Lahey Clinic. The registered enrollment target is 44 participants, below the 259-participant average among 5 other Acute Renal Failure 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
NCT01280617, a NA study of Acute Renal Failure, has completed, sponsored by Lahey Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.
Primary Outcome
Incidence of Biopsy Proven Acute Rejection at 1 year post transplant:
Conditions Studied
Interventions
- DRUG Thymoglobulin
- DRUG Thymoglobulin 0.75mg/kg dose
Study Locations (1)
Massachusetts
- Lahey Clinic - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01280617 record still lists
NCT01280617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 259-participant average among 5 other Acute Renal Failure trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Acute Renal Failure appearing as the primary indexed condition, and to 2 interventions - of which Thymoglobulin is the first listed.
NCT01280617 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01280617 about?
NCT01280617 is a clinical study titled "Low Dose Thymoglobin in Renal Transplant Patients". This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patient...
What is the current status of trial NCT01280617?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2010-10. Estimated completion is 2014-01.
What conditions does trial NCT01280617 study?
This clinical trial studies the following conditions: Acute Renal Failure.
What interventions are being tested in trial NCT01280617?
The interventions under investigation include: Thymoglobulin (DRUG), Thymoglobulin 0.75mg/kg dose (DRUG).
Who is sponsoring clinical trial NCT01280617?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01280617 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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