Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
NCT00038948
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- 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
- 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
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |