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Study Evaluating Sirolimus in Kidney Transplant Recipients.

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Roma, Lazio, 00144 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Failure, Graft vs Host Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age is older than 18 years.

- End-stage renal disease, with subjects scheduled for kidney transplant.

- Women of childbearing potential must not be pregnant and agree to medically acceptable
method of contraception throughout the treatment period and for 3 months following
discontinuation of assigned treatment.

Other inclusion applies.

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

- Evidence of active systemic or localized major infection.

- Use of any investigational drug or treatment up to 4 weeks prior to study entry.

- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics,
corticosteroids, basiliximab.

- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs
other than renal transplant).

- Immunosuppression therapies other than those allowed in the protocol.

- Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or
ketoconazole (all known to interact with SRL) that is not discontinued prior to study
entry.

Other exclusion applies.

NCT00167947
Pfizer
Completed
Study Evaluating Sirolimus in Kidney Transplant Recipients.

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Study Evaluating Sirolimus in Kidney Transplant Recipients.
A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.
Renal function at 12 months assessed by calculated creatinine clearance.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Failure
  • Graft vs Host Disease
  • Drug: Cyclosporine
    Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
  • Drug: Steroids
    Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
  • Drug: Rapamune (Sirolimus)
    Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
  • Active Comparator: A
    Interventions:
    • Drug: Cyclosporine
    • Drug: Steroids
    • Drug: Rapamune (Sirolimus)
  • Experimental: B
    Interventions:
    • Drug: Cyclosporine
    • Drug: Steroids
    • Drug: Rapamune (Sirolimus)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age is older than 18 years.
  • End-stage renal disease, with subjects scheduled for kidney transplant.
  • Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusion applies.

Exclusion Criteria:

  • Evidence of active systemic or localized major infection.
  • Use of any investigational drug or treatment up to 4 weeks prior to study entry.
  • Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
  • Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
  • Immunosuppression therapies other than those allowed in the protocol.
  • Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.

Other exclusion applies.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00167947
0468E-101629
No
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 Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
March 2008

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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[email protected]



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