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Trial record 1 of 1 for:    NCT00452361
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Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

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ClinicalTrials.gov Identifier: NCT00452361
Recruitment Status : Terminated
First Posted : March 27, 2007
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE March 23, 2007
First Posted Date  ICMJE March 27, 2007
Results First Submitted Date  ICMJE September 24, 2009
Results First Posted Date  ICMJE September 3, 2012
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
Change in Glomerular Filtration Rate (GFR) Change From Baseline [ Time Frame: 104 weeks ]
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
To determine the effect of conversion from CI- to SRL based therapy on renal function 104 weeks after randomization, as indicated by the change from baseline Nankivell GFR.
Change History Complete list of historical versions of study NCT00452361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
  • Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 24 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
  • Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 52 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
  • Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 104 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
  • Patient and Graft Survival [ Time Frame: Week 24 ]
    Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
  • Patient and Graft Survival [ Time Frame: Week 52 ]
    Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
  • Patient and Graft Survival [ Time Frame: Week 104 ]
    Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
  • Change From Baseline in Diastolic Blood Pressure at Week 24 [ Time Frame: Baseline and Week 24 ]
    Value at Week 24 minus value at baseline.
  • Change From Baseline in Diastolic Blood Pressure at Week 52 [ Time Frame: Baseline and Week 52 ]
    Value at Week 52 minus value at baseline.
  • Change From Baseline in Diastolic Blood Pressure at Week 104 [ Time Frame: Baseline and Week 104 ]
    Value at Week 104 minus value at baseline.
  • Change From Baseline in Systolic Blood Pressure at Week 24 [ Time Frame: Baseline and Week 24 ]
    Value at Week 24 minus value at baseline.
  • Change From Baseline in Systolic Blood Pressure at Week 52 [ Time Frame: Baseline and Week 52 ]
    Value at Week 52 minus value at baseline.
  • Change From Baseline in Systolic Blood Pressure at Week 104 [ Time Frame: Baseline and Week 104 ]
    Value at Week 104 minus value at baseline.
  • Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104 [ Time Frame: Baseline and Week 104 ]
  • Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52 [ Time Frame: Weeks 52 ]
  • Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104 [ Time Frame: Week 104 ]
  • Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24 [ Time Frame: Week 24 ]
  • Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52 [ Time Frame: Week 52 ]
  • Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104 [ Time Frame: Week 104 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
Incidence and severity of rejection at 24, 52, 104 weeks; GFR at 24, 52, 104 weeks; patient and graft survival at 24, 52 and 104 weeks; blood presure at 24, 52, 104 weeks; severity and progression of biopsy-confirmed CAN at 104 weeks. To assess safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
Official Title  ICMJE A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
Brief Summary This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).
Detailed Description

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.

The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).

Dosage and Administration

SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:

  • triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
  • corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
  • either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.

SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • Drug: Sirolimus+MMF or MPS or AZA+Steroid
    Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
  • Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

    The maintenance dose of:

    1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
    2. AZA will not exceed 75 mg/day

    Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:

    1. continued for the entire 104-week period of randomized therapy
    2. subsequently discontinued
    3. restarted after discontinuation
Study Arms  ICMJE
  • Experimental: 1
    Sirolimus therapy
    Intervention: Drug: Sirolimus+MMF or MPS or AZA+Steroid
  • Active Comparator: 2
    Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
    Intervention: Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)
31
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
120
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be at least 18 years of age.
  • Subjects who are 6 to 60 months after renal transplantation.
  • Subjects who have a stable graft function.

Exclusion Criteria:

  • Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.
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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452361
Other Study ID Numbers  ICMJE 0468H-101864
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP