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 : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Renal Failure||Drug: Thymoglobulin Drug: Thymoglobulin 0.75mg/kg dose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
Other Name: Thymoglobulin
- 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.
- 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.
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
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||Hannah M. Gilligan, MD||Lahey Clinic|