N/A
Completed N=44
Low Dose Thymoglobin in Renal Transplant Patients
Acute Renal Failure
Source: ClinicalTrials.gov NCT01280617 ↗
Enrolled (actual)
44
Serious AEs
11.6%
Results posted
Mar 2021
Primary outcomePrimary: Rates of Acute Cellular Rejection Between Study Group — 4; 2 Number of rejection — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Acute Cellular Rejection Between Study Group |
4; 2 | <0.05 sig |
| SECONDARY , "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy" |
3; 8 | — |
Eligibility Criteria
Inclusion Criteria
Potential Adult Renal Transplant Patients -
Exclusion Criteria
Sensitized Renal Transplant Patients
-
Data sourced from ClinicalTrials.gov (NCT01280617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.