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Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Living Donor Renal Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681343
First Posted: May 21, 2008
Last Update Posted: May 29, 2008
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
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

Condition Intervention Phase
Living-Donor Kidney Transplant Drug: Thymoglobulin Drug: Campath-1H Drug: Daclizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:
  • Incidence and severity of biopsy-proven acute rejection at 1 year. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Patient and graft survival [ Time Frame: 1 and 3 years ]
  • Incidence of biopsy-proven chronic allograft nephropathy. [ Time Frame: 1 and 3 years ]
  • Levels of lymphoid cell subsets. [ Time Frame: 1 and 3 years ]
  • Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events. [ Time Frame: 1 and 3 years ]

Enrollment: 38
Study Start Date: September 2002
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Thymoglobulin Induction
Drug: Thymoglobulin
Induction
Experimental: B
Campath-1H Induction
Drug: Campath-1H
Induction
Other Name: Alemtuzumab
Experimental: C
Daclizumab Induction
Drug: Daclizumab
Induction
Other Name: Zenapax

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (36 months). Parent or legal guardian must provide written consent for patients <18 years of age.
  2. Age 16-65 years
  3. Weight > 40 kg
  4. Primary renal allograft: living related (non HLA identical) and unrelated donor
  5. Negative standard cross-match for T-cells. All donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center)
  6. Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for 3 months following discontinuation of Thymoglobulin or Campath-1H
  7. Males and females are to be studied equivalently as they become available for transplantation using these criteria.

Exclusion Criteria:

  1. Patient has previously received or is receiving an organ transplant other than a kidney.
  2. Patient is receiving an ABO incompatible donor kidney.
  3. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
  4. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
  5. Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
  6. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
  7. Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
  8. Patient will be receiving any immunosuppressive agent other that those prescribed in the study.
  9. Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e. skin closure).
  10. Patient is receiving or may require warfarin, fluvastatin or herbal supplements during the study.
  11. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
  12. Patient has a known hypersensitivity to Tacrolimus, Campath-1H, Thymoglobulin, Daclizumab (Zenapax®), Sirolimus, MMF or corticosteroids.
  13. Patient is pregnant or lactating.
  14. Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count <4000/mm3; platelet count <100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol <30 mg/dl; fasting LDL-cholesterol >200mg/dl.
  15. Patient is unlikely to comply with the visits scheduled in the protocol.
  16. Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
  17. If tacrolimus cannot be instituted for longer than 5 days postoperatively.
  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): NCT00681343


Locations
United States, Florida
University of Miami Division of Transplantation
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Hoffmann-La Roche
Investigators
Principal Investigator: George W Burke University of Miami
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George W. Burke, University of Miami
ClinicalTrials.gov Identifier: NCT00681343     History of Changes
Other Study ID Numbers: IRB#20010704
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by University of Miami:
Randomized
study
effectiveness/toxicity
induction therapy
recipients

Additional relevant MeSH terms:
Thymoglobulin
Antilymphocyte Serum
Daclizumab
Immunoglobulin G
Alemtuzumab
Calcineurin Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action