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.

Study Overview

• Status: Completed
• Conditions: Graft vs Host Disease; Kidney Failure
• Intervention / Treatment: Drug: Cyclosporine; Drug: Steroids; Drug: Rapamune (Sirolimus)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70100
  • Bologna, Italy, 40138
  • Cagliari, Italy, 09125
  • Firenze, Italy, 50139
  • L'Aquila, Italy, 67100
  • Milano, Italy, 20162
  • Pisa, Italy, 56100
  • Sassari, Italy, 07100
  • Siena, Italy, 53100
  • Udine, Italy, 37100
  • Varese, Italy, 21100
  • Lazio
    • Roma, Lazio, Italy, 00144
    • Roma, Lazio, Italy, 00168
  • Sicily
    • Palermo, Sicily, Italy, 90127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	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 "
Experimental: B	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 "

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Italy, decresg@wyeth.com

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): March 14, 2008
• Last Update Submitted That Met QC Criteria: March 13, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Transplant; Kidney
• Additional Relevant MeSH Terms: Immune System Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Graft vs Host Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Calcineurin Inhibitors; Sirolimus; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 0468E-101629