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Trial record 1 of 1 for:    NCT00038948
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Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00038948
Recruitment Status : Completed
First Posted : June 7, 2002
Results First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE June 5, 2002
First Posted Date  ICMJE June 7, 2002
Results First Submitted Date  ICMJE May 29, 2009
Results First Posted Date  ICMJE May 14, 2010
Last Update Posted Date May 14, 2010
Study Start Date  ICMJE January 2002
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Nankivell Glomerular Filtration Rate (GFR) [ Time Frame: 52 weeks ]
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00038948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. [ Time Frame: 52 and 104 weeks ]
Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
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 Recipients
Brief Summary The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Transplantation
Intervention  ICMJE
  • Drug: Sirolimus
    Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
  • Drug: tacrolimus
  • Drug: Cyclosporine A
Study Arms  ICMJE
  • Active Comparator: A
    Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
    Interventions:
    • Drug: Sirolimus
    • Drug: tacrolimus
    • Drug: Cyclosporine A
  • Active Comparator: B
    Continued calcineurin inhibitor therapy
    Interventions:
    • Drug: Sirolimus
    • Drug: tacrolimus
    • Drug: Cyclosporine A
Publications * Reichen J, Stickel F, Bhattacharya I, Matschke K, Maller E, Korth-Bradley J. Repeat-dose sirolimus pharmacokinetics and pharmacodynamics in patients with hepatic allografts. Eur J Clin Pharmacol. 2012 May;68(5):589-97. doi: 10.1007/s00228-011-1172-7. Epub 2011 Dec 6.

*   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: December 19, 2007)
830
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than or equal to 13 years.
  • Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
  • Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

  • Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
  • Patients in whom kidney-pancreas or other multiple organ transplants have been performed
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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00038948
Other Study ID Numbers  ICMJE 0468H1-316
Has Data Monitoring Committee Yes
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, MD 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