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Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Rochester, New York, 14642 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atherosclerosis, Kidney Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

At least one of the following characteristics:

- History of dialysis for at least 3 years.

- History of diabetes for at least 5 years.

- Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss
of the first transplant.

- History of coronary artery disease, stroke, myocardial infarction, or amputation for
vascular disease.

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

- History of malignancy within the last 5 years (except adequately treated skin cancer).

- Recipients of non-renal organ transplant.

- Active gastrointestinal disease that may interfere with drug absorption.

- Active HIV, hepatitis B or C infection.

- Women who are pregnant or breastfeeding.

NCT00311311
Pfizer
Terminated
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

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Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.

A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011.

The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atherosclerosis
  • Kidney Failure
  • Drug: tacrolimus
    The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
    Other Name: CNI
  • Drug: mycophenolate mofetil
    The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ? 500 mg/day or MPS ? 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ? 500 mg/day dose or MPS is to be continued at ? 360 mg/day dose through to the end of study.
    Other Name: MMF, MPS
  • Drug: prednisone
    The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
    Other Name: CCS
  • Drug: sirolimus

    The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.

    On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant.

  • Drug: tacrolimus
    The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
    Other Name: CNI
  • Active Comparator: 1
    Tacrolimus + MMF + Steroids
    Interventions:
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: prednisone
  • Experimental: 2
    Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
    Interventions:
    • Drug: sirolimus
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: prednisone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
January 2012
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

At least one of the following characteristics:

  • History of dialysis for at least 3 years.
  • History of diabetes for at least 5 years.
  • Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
  • History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.

Exclusion Criteria:

  • History of malignancy within the last 5 years (except adequately treated skin cancer).
  • Recipients of non-renal organ transplant.
  • Active gastrointestinal disease that may interfere with drug absorption.
  • Active HIV, hepatitis B or C infection.
  • Women who are pregnant or breastfeeding.
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00311311
0468H1-319
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

ICMJE     Data element required by the

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

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