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Completed

NCT Number: NCT01046955

Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Drug

comparison of induction therapies.

Other names: Thymoglobulin, Zenapax

Primary outcomes

  1. 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

  2. Patient/graft survival.

    Time frame: 1 and 3 yrs.

Secondary outcomes

  1. Incidence of adverse reactions.

    Time frame: 1 & 3 years.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jan 12, 2010
Registry last updated
Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.