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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00681343
First received: May 19, 2008
Last updated: May 23, 2008
Last verified: May 2008
  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
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 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 ] [ Designated as safety issue: Yes ]

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

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

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

No publications provided

Responsible Party: George W. Burke, University of Miami
ClinicalTrials.gov Identifier: NCT00681343     History of Changes
Other Study ID Numbers: IRB#20010704
Study First Received: May 19, 2008
Last Updated: May 23, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Daclizumab
Campath 1G
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014