Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

University of Miami

Status and phase: Completed; Phase 4

Conditions: End-Stage Renal Disease; Living Donors

Treatments: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01046955

20010704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 3 patient groups

1mg/kg Thymoglobulin

Active Comparator group

Description:

LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.

Treatment:

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Campath-1H at 0.3 mg/kg

Active Comparator group

Description:

Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.

Treatment:

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Zenapax 1 mg/kg

Active Comparator group

Description:

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.

Treatment:

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab