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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Patient/graft survival. [ Time Frame: 1 and 3 yrs. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse reactions. [ Time Frame: 1 & 3 years. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: George Burke, University of Miami
ClinicalTrials.gov Identifier: NCT01046955     History of Changes
Other Study ID Numbers: 20010704
Study First Received: January 11, 2010
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
ESRD

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Alemtuzumab
Antilymphocyte Serum
Daclizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 16, 2014