"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
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|ClinicalTrials.gov Identifier: NCT00365846|
Recruitment Status : Completed
First Posted : August 18, 2006
Results First Posted : July 30, 2012
Last Update Posted : October 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Campath-1H||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2006|
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,
- Incidence of Allograft Rejection [ Time Frame: 3 years ]
- Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) [ Time Frame: 3 years ]
- Patient Survival [ Time Frame: 3 years ]
- Incidence of Post-transplant Infection [ Time Frame: 3 years ]Event of post-transplant infection (more than one "event" might have been counted per participant)
- Incidence of Malignancies [ Time Frame: 3 years ]Number of Participants Experiencing Malignancies
- Kidney Allograft Survival [ Time Frame: 3 years ]
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): NCT00365846
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Stuart J Knechtle||University of Wisconsin, Madison|