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Trial record 1 of 1 for:    NCT00478608
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Study Evaluating Rapamune® Maintenance Regimen

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ClinicalTrials.gov Identifier: NCT00478608
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : January 7, 2010
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 25, 2007
Results First Submitted Date  ICMJE November 30, 2009
Results First Posted Date  ICMJE January 7, 2010
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE March 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. [ Time Frame: 6 months after transplantation ]
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
Primary efficacy endpoint is the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation.
Change History Complete list of historical versions of study NCT00478608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Glomerular Filtration Rate (GFR) (Nankivell Method) [ Time Frame: 6 and 12 months ]
    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. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.
  • Serum Creatinine [ Time Frame: Baseline, 6 and 12 months ]
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.
  • Patient and Graft Survival [ Time Frame: 12 months ]
    Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients 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.
  • Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation [ Time Frame: 12 months after transplantation ]
    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
1. To evaluate graft function 2. To evaluate subject and graft survival at 3 and 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Rapamune® Maintenance Regimen
Official Title  ICMJE A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients
Brief Summary

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

  1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
  2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Renal Transplant
Intervention  ICMJE Drug: Sirolimus (Rapamune®)
(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.
Study Arms  ICMJE Not Provided
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: November 30, 2009)
79
Original Enrollment  ICMJE
 (submitted: May 24, 2007)
70
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age greater than or equal to 13 years of age.
  2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
  3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion Criteria:

  1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
  2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
  3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
  4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
  5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, 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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00478608
Other Study ID Numbers  ICMJE 0468E-102362
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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 April 2010

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