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Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01046955
First received: January 11, 2010
Last updated: NA
Last verified: May 2008
History: No changes posted

January 11, 2010
January 11, 2010
November 2005
April 2007   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Patient/graft survival. [ Time Frame: 1 and 3 yrs. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Incidence of adverse reactions. [ Time Frame: 1 & 3 years. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • End-Stage Renal Disease
  • Living Donors
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax
  • Active Comparator: 1mg/kg Thymoglobulin
    LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
    Intervention: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
  • 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.
    Intervention: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
  • 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.
    Intervention: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2008
April 2007   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01046955
20010704
No
George Burke, University of Miami
University of Miami
Hoffmann-La Roche
Principal Investigator: George W Burke, M.D. University of Miami
University of Miami
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP