Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• 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 "

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Experimental: B

Primary Measures

• To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
  • Time Frame: 6 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00167947

Study ID Number: 0468E-101629

ClinicalTrials.gov Identifier: NCT00167947

Health Authority: Italy: Ministry of Health