A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Campath-1H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary renal transplant (not HLA identical) ages 18-60 years Exclusion Criteria: recipient panel reactive antibody level >10% recipient of a DCD kidney no prior organ transplant no multi-organ transplant recipient no subject who is currently receiving systemic corticosteroids no pregnant or lactating subjects no history of Hepatitis B, C or HIV positivity no recipient of a kidney with cold ischemia time >36 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Campath 1H induction w/ Sirolimus immunosuppression<br>Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus, | Drug: Campath-1H<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Allograft Rejection |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) |  | 3 years | 
| Patient Survival |  | 3 years | 
| Incidence of Post-transplant Infection | Event of post-transplant infection (more than one event might have been counted per participant) | 3 years | 
| Incidence of Malignancies | Number of Participants Experiencing Malignancies | 3 years | 
| Kidney Allograft Survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevent kidney rejection