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Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease; Living Donors

Intervention: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Miami

Official(s) and/or principal investigator(s):
George W Burke, M.D., Principal Investigator, Affiliation: University of Miami

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

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.

Patient/graft survival.

Secondary outcome: Incidence of adverse reactions.

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.

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Miami Jackson Memorial Hospital, Miami, Florida 33136, United States
Additional Information

Starting date: November 2005
Last updated: January 11, 2010

Page last updated: August 23, 2015

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