Study Evaluating Sirolimus in Kidney Transplant Recipients.

Kidney Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167947
• Other study ID #: 0468E-101629
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 13, 2008
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: March 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Renal function at 12 months assessed by calculated creatinine clearance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Failure
• Renal Insufficiency

Intervention

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 "
• 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 "
• 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 "

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	Yes