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Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046955
First Posted: January 12, 2010
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Miami
  Purpose
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.

Condition Intervention Phase
End-Stage Renal Disease Living Donors Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Incidence of adverse reactions. [ Time Frame: 1 & 3 years. ]

Enrollment: 38
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1mg/kg Thymoglobulin
LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax
Active Comparator: Campath-1H at 0.3 mg/kg
Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax
Active Comparator: Zenapax 1 mg/kg
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.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax

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

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046955


Locations
United States, Florida
University of Miami Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Hoffmann-La Roche
Investigators
Principal Investigator: George W Burke, M.D. University of Miami
  More Information

Responsible Party: George Burke, University of Miami
ClinicalTrials.gov Identifier: NCT01046955     History of Changes
Other Study ID Numbers: 20010704
First Submitted: January 11, 2010
First Posted: January 12, 2010
Last Update Posted: January 12, 2010
Last Verified: May 2008

Keywords provided by University of Miami:
ESRD

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Thymoglobulin
Antilymphocyte Serum
Daclizumab
Alemtuzumab
Calcineurin Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action