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Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305396
First Posted: March 21, 2006
Last Update Posted: March 21, 2006
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:
Genzyme, a Sanofi Company
Information provided by:
Vanderbilt University
  Purpose
A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

Condition Intervention Phase
Kidney Transplantation Drug: Sirolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Patient and graft survival
  • Biopsy proven acute rejection
  • Serum creatinine

Secondary Outcome Measures:
  • Hyperlipidemia
  • post-transplant diabetes
  • wound infections
  • lymphoceles

Estimated Enrollment: 80
Study Start Date: April 2004
Estimated Study Completion Date: March 2005
Detailed Description:
Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Primary cadaver or non-HLA identical living donor kidney transplant. -

Exclusion Criteria:

HIV HCV Pregnancy Age < 18 years Malignancy

  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): NCT00305396


Locations
United States, Tennessee
Vanderbilt University Medical Center/Nashville VA
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Genzyme, a Sanofi Company
Investigators
Principal Investigator: A. Tarik Kizilisik, M.D. Vanderbilt University Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00305396     History of Changes
Other Study ID Numbers: 031041
First Submitted: March 20, 2006
First Posted: March 21, 2006
Last Update Posted: March 21, 2006
Last Verified: March 2006

Keywords provided by Vanderbilt University:
Kidney transplantation
immunosuppression
sirolimus
Thymoglobulin

Additional relevant MeSH terms:
Sirolimus
Everolimus
Thymoglobulin
Antilymphocyte Serum
Calcineurin Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action