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

Last updated on November 19, 2019

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Study Location
Pfizer Investigational Site
La Jolla, California, 92037 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00895583
Pfizer
Completed
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients

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Descriptive Information
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 SummaryThis 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 DescriptionNot 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
  • Graft Rejection
  • Kidney Transplant
  • Renal Allograft Recipients
  • Renal Transplant
Intervention  ICMJE
  • Drug: Tacrolimus
    During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days).
    Other Name: Prograf, Adagraf
  • Drug: Sirolimus
    Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months).
    Other Name: Rapamune
  • Drug: Tacrolimus
    During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.
    Other Name: Prograf, adagraf
Study Arms  ICMJE
  • Experimental: Group I - Planned transition to sirolimus from tacrolimus
    Interventions:
    • Drug: Tacrolimus
    • Drug: Sirolimus
  • Active Comparator: Group II - Continuation of tacrolimus
    Intervention: Drug: Tacrolimus
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
 (submitted: September 15, 2014)
254
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2009)
300
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion DateAugust 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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