Low Dose Thymoglobin in Renal Transplant Patients
|ClinicalTrials.gov Identifier: NCT01280617|
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : May 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Renal Failure||Drug: Thymoglobulin Drug: Thymoglobulin 0.75mg/kg dose||Not Applicable|
Show Detailed Description
|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.
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|