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Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Last updated on August 9, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT00038948
Pfizer
Completed
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

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Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Transplantation
  • Drug: Sirolimus
    Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
  • Drug: tacrolimus
  • Drug: Cyclosporine A
  • 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
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.
 
Completed
830
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00038948
0468H1-316
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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