"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation|
- Incidence of Allograft Rejection [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Patient Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Incidence of Post-transplant Infection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Event of post-transplant infection (more than one "event" might have been counted per participant)
- Incidence of Malignancies [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Number of Participants Experiencing Malignancies
- Kidney Allograft Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2000|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Experimental: Campath 1H induction w/ Sirolimus immunosuppression
Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.
Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365846
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Stuart J Knechtle||University of Wisconsin, Madison|