Low Dose Thymoglobin in Renal Transplant Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01280617 |
Recruitment Status
:
Completed
First Posted
: January 21, 2011
Last Update Posted
: May 29, 2014
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 19, 2011 | |||
First Posted Date ICMJE | January 21, 2011 | |||
Last Update Posted Date | May 29, 2014 | |||
Study Start Date ICMJE | October 2010 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Evaluate the rates of acute cellular rejection between study groups [ Time Frame: 1 year ] Data from study participants will be collected for up to 1 year post-transplant.
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01280617 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Evaluate the rates of infections, leucopenia and malignacy between study groups [ Time Frame: 1 year ] Data from study participants will be collected for up to 1 year post-transplant.
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Low Dose Thymoglobin in Renal Transplant Patients | |||
Official Title ICMJE | Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients | |||
Brief 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. | |||
Detailed 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:
During each of the clinic visits the investigators will obtain the following information:
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. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Acute Renal Failure | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
58 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Potential Adult Renal Transplant Patients - Exclusion Criteria: Sensitized Renal Transplant Patients |
|||
Sex/Gender |
|
|||
Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01280617 | |||
Other Study ID Numbers ICMJE | 2010-065 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Lahey Clinic | |||
Study Sponsor ICMJE | Lahey Clinic | |||
Collaborators ICMJE | Brigham and Women's Hospital | |||
Investigators ICMJE |
|
|||
PRS Account | Lahey Clinic | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |