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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 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Renal Failure
 Drug: Thymoglobulin
Drug: Thymoglobulin 0.75mg/kg dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Dose Thymoglobulin As Induction Agent on Predbisone-Free Regimens of Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Thymoglobulin
Thymoglobulin 1.25mg/kg dose
Other Name: 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.
 Drug: Thymoglobulin 0.75mg/kg dose
Thymoglobulin
Other Name: Thymoglobulin

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  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Potential Adult Renal Transplant Patients -

Exclusion Criteria:

Sensitized Renal Transplant Patients

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280617

Contacts
Contact: Monica Grafals, MD 781-744-2500 monica.grafals@lahey.org

Locations
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Monica Grafals, MD     781-744-2500     monica.grafals@lahey.org    
Sub-Investigator: James Pomposelli, MD            
Sub-Investigator: Khalid Kwaja, MD            
Sub-Investigator: Hannah Gilligan, MD            
Sub-Investigator: Mohamed Akoud, MD            
Sub-Investigator: Mary Anne Simpson            
Sub-Investigator: Elizabeth Pomfret, MD            
Sponsors and Collaborators
Lahey Clinic
Brigham and Women's Hospital
Investigators
Principal Investigator: Monica Grafals, MD Lahey Clinic
  More Information

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT01280617     History of Changes
Other Study ID Numbers: 2010-065
Study First Received: January 19, 2011
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lahey Clinic:
Renal Transplant
Thymoglubulin

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013