Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients

Completed · Phase 4

Conditions studied: Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant

In brief

This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

Key facts

Study ID

NCT00895583

Run by

Pfizer

People needed

254

Starts

2009-06-01

Expected to finish

2013-08-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At Screening:
• Male or female subjects aged 18 years or older.
• Recipients who are 14 days prior to transplantation up through 14 days after transplantation.
• Recipients of a primary, living- or deceased-donor renal allograft.
• All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article. A subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
• At Randomization:
• Ninety (90) to 150 days post-transplantation.
• Treatment with tacrolimus and an inosine monophosphate dehydrogenase (IMPDH) inhibitor initiated less than or equal to 30 days of transplantation and has remained on both for the 30 days prior to randomization.

You may not qualify if…

• At Screening:
• Recipients of multiple organ transplants (i.e., any prior or concurrent transplantation of any organs including prior renal transplant. )
• Recipients of adult or pediatric en bloc kidney transplants.
• Recipients who required or will require desensitization protocols.
• Known history of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis (MPGN).
• Evidence of active systemic or localized major infection, as determined by the investigator.
• Received any investigational drugs or devices less than or equal to 30 days prior to transplantation.
• Known or suspected allergy to sirolimus (SRL), tacrolimus (TAC), inosine-monophosphate dehydrogenase (IMPDH) inhibitor, macrolide antibiotics, iothalamate, iodine, iodine-containing products, including contrast media other compounds related to these products/classes of medication, or shellfish.
• History of malignancy less than or equal to 3 years of screening (except for adequately treated basal cell or squamous cell carcinoma of the skin).
• Recipients who are known to be human immunodeficiency virus (HIV) positive.
• Women who are biologically capable of having children with a positive urine or serum pregnancy test at screening.
• Breastfeeding women.
• At Randomization:
• Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
• Planned treatment with immunosuppressive therapies other than those described in the protocol.
• Subjects who underwent corticosteroids withdrawal or avoidance and did not receive antibody induction at the time of transplantation with anti-thymocyte globulin (rabbit) (rATG) (Thymoglobulin®), anti-thymocyte globulin (equine) (Atgam®), or alemtuzumab (Campath®).
• Subjects who have had corticosteroid (CS) discontinued less than or equal to 30 days before randomization.
• Calculated glomerular filtration rate (GFR) less than 40 mL/min/1.73m2 using the simplified Modification of Diet in Renal Disease (MDRD) formula less than or equal to 2 weeks prior to randomization.
• Spot urine protein to creatinine ratio (UPr/Cr) greater than or equal to 0.5 less than or equal to 2 weeks prior to randomization.
• Banff (2007) grade 2 or higher acute T-cell-mediated or any acute antibody-mediated rejection at any time post-transplantation.
• Any acute rejection (biopsy-confirmed or presumed) less than or equal to 30 days before randomization.
• More than 1 episode of acute rejection (biopsy-confirmed or presumed).
• Known Banff (2007) interstitial fibrosis and tubular atrophy (IF/TA) greater than or equal to grade 2 or recurrent/de novo glomerular disease.
• Major surgery less than or equal to 2 weeks prior to randomization.
• Active post-operative complication, e.g. infection, delayed wound healing.

Where it is running

• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Portland, Maine, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Chapel Hill, North Carolina, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Charleston, South Carolina, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Charlottesville, Virginia, United States
• Pfizer Investigational Site — Charlottesville, Virginia, United States
• Pfizer Investigational Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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