Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
NCT00895583
ABOUT THIS STUDY
FOR MORE INFORMATION
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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.
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.
- Total white blood cell count less than 2,000/mm3 or absolute neutrophil count (ANC)
less than 1000 or platelet count less than 100,000/mm3 less than or equal to 2 weeks
prior to randomization.
- Fasting triglycerides greater than 400 mg/dL (greater than 4.5 mmol/L) or fasting
total cholesterol greater than 300 mg/dL (greater than 7.8 mmol/L) less than or equal
to 2 weeks prior to randomization regardless of whether or not on lipid-lowering
therapy.
- Women who are biologically capable of having children with a positive urine or serum
pregnancy test at randomization.
- Breastfeeding women.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients | |||
Official Title ICMJE | Planned Transition To Sirolimus-Based Therapy Versus Continued Tacrolimus-Based Therapy In Renal Allograft Recipients | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 254 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | August 2013 | |||
Actual Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: At Screening:
At Randomization:
Exclusion Criteria: At Screening:
At Randomization:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Germany, Italy, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00895583 | |||
Other Study ID Numbers ICMJE | 0468E8-4500 B1741007 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |