Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.

Detailed Description
-----------------
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra). To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively. To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.

Official Title
-----------------
Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy

Conditions
-----------------
End-Stage Renal Disease, Living Donors

Intervention / Treatment
-----------------
* Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >14 years Weight >40 kg Primary renal allograft:living related (non HLA identical) and unrelated donor Negative standard cross match for T-cells Signed and dated consent form Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than kidney Patient has received a kidney transplant from a non-heart beating donor Patient has received an ABO incompatible donor kidney Recipient or donor is seropositive for human immunodeficiency virus (HIV) Patient has a current malignancy or a history of malignancy

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1mg/kg Thymoglobulin<br>LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery. | Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab<br>* comparison of induction therapies.<br>* Other names: Zenapax;|
| Active Comparator: Campath-1H at 0.3 mg/kg<br>Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively. | Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab<br>* comparison of induction therapies.<br>* Other names: Zenapax;|
| Active Comparator: Zenapax 1 mg/kg<br>Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages. | Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab<br>* comparison of induction therapies.<br>* Other names: Zenapax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys. |  | 3 years | 
| Patient/graft survival. |  | 1 and 3 yrs. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions. |  | 1 & 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESRD