Low Dose Thymoglobin in Renal Transplant Patients

This study is currently recruiting participants.
Verified October 2012 by Lahey Clinic
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT01280617
First received: January 19, 2011
Last updated: October 10, 2013
Last verified: October 2012

January 19, 2011
October 10, 2013
October 2010
January 2014   (final data collection date for primary outcome measure)
Evaluate the rates of acute cellular rejection between study groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Data from study participants will be collected for up to 1 year post-transplant.
Same as current
Complete list of historical versions of study NCT01280617 on ClinicalTrials.gov Archive Site
Evaluate the rates of infections, leucopenia and malignacy between study groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Data from study participants will be collected for up to 1 year post-transplant.
Same as current
Not Provided
Not Provided
 
Low Dose Thymoglobin in Renal Transplant Patients
Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients

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 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Renal Failure
  • Drug: Thymoglobulin
    Thymoglobulin 1.25mg/kg dose
    Other Name: Thymoglobulin
  • Drug: Thymoglobulin 0.75mg/kg dose
    Thymoglobulin
    Other Name: Thymoglobulin
  • Experimental: Thymoglobulin 1.25mg/kg dose
    The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
    Intervention: Drug: Thymoglobulin
  • Experimental: Thymoglobulin 0.75mg/kg dose
    The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
    Intervention: Drug: Thymoglobulin 0.75mg/kg dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Potential Adult Renal Transplant Patients -

Exclusion Criteria:

Sensitized Renal Transplant Patients

-

Both
18 Years to 80 Years
No
Contact: Hannah M. Gilligan, MD 781-744-2500 hannah.m.gilligan@lahey.org
United States
 
NCT01280617
2010-065
No
Lahey Clinic
Lahey Clinic
Brigham and Women's Hospital
Principal Investigator: Hannah M. Gilligan, MD Lahey Clinic
Lahey Clinic
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP