Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00685061
First received: May 23, 2008
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first cadaver (CAD) kidneys.


Condition Intervention Phase
Renal Transplantation
Drug: Thymoglobulin
Drug: Campath-1H
Drug: Daclizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • One-year and 3 year patient and graft survival. [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: November 2002
Study Completion Date: September 2005
Primary Completion Date: September 2004 (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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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 cadaver renal allograft
  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 (HIV), or 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 and/or is taking or has been taking 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, mycophenolate 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
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: NCT00685061

Locations
United States, Florida
University of Miami Division of Transplantation
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George W. Burke, University of Miami Division of Transplantation
ClinicalTrials.gov Identifier: NCT00685061     History of Changes
Other Study ID Numbers: IRB#20020213
Study First Received: May 23, 2008
Last Updated: May 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Adult, primary deceased donor kidney transplant recipients

Additional relevant MeSH terms:
Alemtuzumab
Daclizumab
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014