Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01280617 |
Other study ID # |
2010-065 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2010 |
Est. completion date |
January 2014 |
Study information
Verified date |
February 2021 |
Source |
Lahey Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Detailed Study Design:
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.
The investigators will obtain the following information at the time of consent:
1. Type of renal transplant (living vs cadaveric)
2. HLA matching
3. CMV status of donor and recipient
4. EBV status of donor and recipient
5. Creatinine prior to transplantation
6. Urinalysis at the time of transplantation
7. Primary renal disease
8. Weight of the renal transplant
9. BMI of the recipient and donor
10. Age of the donor and recipient
11. Sex of the donor and recipient
12. White blood cell count
13. Hemoglobin
14. Platelets
15. History of infections
16. History of malignancies
During each of the clinic visits the investigators will obtain the following information:
1. Creatinine
2. Urinalysis
3. White blood cell count
4. Hemoglobin
5. Platelets
6. Weight of the recipient
7. Infections
8. Malignancies
9. Renal biopsy report if a biopsy was performed
In addition to the standard of care laboratories, the investigators will ask patients to give
us 7 additional green tubes, one purple tube and two red tubes which will be drawn at the
time of standard of care laboratories pre-transplantation, 3 months post-transplant, 6 months
post-transplant and 12 months post-transplant. This tubes will be used to measure CD4, CD8,
CD19, CD20, CD68 cells as these are cells that are believed to be affected by the use of
thymoglobulin.
If the patient is to have a renal transplant biopsy at any time during the 12 months of the
study, any excess tissue may be utilized for staining of special cell markers including CD4,
CD8, CD19, CD20 and CD68.
Subject inclusion criteria: Potential adult renal transplant recipients
Subject exclusion criteria: Sensitized renal transplant recipients
Methods of statistical analysis to be employed in preparation of reports:
The investigators are planning a study with 1 control per experimental subject, an accrual
interval of 24 time units, and additional follow-up after the accrual interval of 12 time
units. In a previous study the median survival time on the control treatment was 36 time
units. If the true hazard ratio (relative risk) of control subjects relative to experimental
subjects is 5, the investigators will need to study 43 experimental subjects and 43 control
subjects to be able to reject the null hypothesis that the experimental and control survival
curves are equal with probability (power) .800. The Type I error probability associated with
this test of this null hypothesis is 0.05. T-tests will be used to compare both groups.
Thymoglobulin (rabbit antithymocyte globulin) is FDA approved for the treatment of acute
cellular rejection. Nevertheless, for at least the past 10 years this medication has been
utilized as induction agent in renal transplant recipients. This is because an induction
agent allows prednisone withdrawal in renal transplant recipients.
Prednisone withdrawal is extremely important in renal transplant recipients as old protocols
that allowed long term prednisone use compromised the long term health of renal transplant
recipients. Not only does prednisone increase markedly the risk of development of diabetes
and osteoporosis, but is also increases drastically the risk of fractures, which is a very
common cause of mortality in long term prednisone renal transplant recipients.