Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

University of Miami38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

End-Stage Renal Disease Living Donors

Interventions

Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabDRUG

comparison of induction therapies.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Jackson Memorial Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Patient/graft survival.

Time frame: 1 and 3 yrs.

Secondary Outcomes

Incidence of adverse reactions.

Time frame: 1 & 3 years.

Data from ClinicalTrials.gov

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