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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
Results First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Lahey Clinic

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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Drug: Thymoglobulin Drug: Thymoglobulin 0.75mg/kg dose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients
Study Start Date : October 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Rates of Acute Cellular Rejection Between Study Group [ Time Frame: 1 year from date of transplant ]
    Incidence of Biopsy Proven Acute Rejection at 1 year post transplant:


Secondary Outcome Measures :
  1. , "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy" [ Time Frame: 1 year from date of transplant ]
    Number of individual adverse events in high versus low dose Thymoglobulin groups will be tabulated and statistical analyses performed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Potential Adult Renal Transplant Patients -

Exclusion Criteria:

Sensitized Renal Transplant Patients

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280617


Locations
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United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Brigham and Women's Hospital
Investigators
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Principal Investigator: Simpson Lahey Hospital & Medical Ctr
Publications of Results:
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT01280617    
Other Study ID Numbers: 2010-065
First Posted: January 21, 2011    Key Record Dates
Results First Posted: March 16, 2021
Last Update Posted: March 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lahey Clinic:
Renal Transplant
Thymoglubulin
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Thymoglobulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents