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

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. Identifier: NCT00681343
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 29, 2008
Hoffmann-La Roche
Information provided by:
University of Miami

May 19, 2008
May 21, 2008
May 29, 2008
September 2002
October 2006   (Final data collection date for primary outcome measure)
Incidence and severity of biopsy-proven acute rejection at 1 year. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00681343 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary 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
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
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Living-Donor Kidney Transplant
  • Drug: Thymoglobulin
  • Drug: Campath-1H
    Other Name: Alemtuzumab
  • Drug: Daclizumab
    Other Name: Zenapax
  • Experimental: A
    Thymoglobulin Induction
    Intervention: Drug: Thymoglobulin
  • Experimental: B
    Campath-1H Induction
    Intervention: Drug: Campath-1H
  • Experimental: C
    Daclizumab Induction
    Intervention: Drug: Daclizumab
Ciancio G, Gaynor JJ, Guerra G, Sageshima J, Chen L, Mattiazzi A, Roth D, Kupin W, Tueros L, Flores S, Hanson L, Vianna R, Burke GW 3rd. Randomized trial of three induction antibodies in kidney transplantation: long-term results. Transplantation. 2014 Jun 15;97(11):1128-38. doi: 10.1097/01.TP.0000441089.39840.66.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2007
October 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
George W. Burke, University of Miami
University of Miami
Hoffmann-La Roche
Principal Investigator: George W Burke 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