Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

Phase 4

Completed

• Conditions: End-Stage Renal Disease; Living Donors
• Interventions: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

• Registration Number: NCT01046955
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-04
• Status Verified: 2008-05
• Study Completion: 2008-12
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Last Update Submitted: 2010-01-11
• Study First Posted: 2010-01-12
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1mg/kg Thymoglobulin	Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab	LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
Campath-1H at 0.3 mg/kg	Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab	Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
Zenapax 1 mg/kg	Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of adverse reactions.	1 & 3 years.

Trial Locations

Locations (1)

University of Miami Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States