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Study Evaluating Sirolimus in Kidney Transplant Recipients.

Primary Purpose

Kidney Failure, Graft vs Host Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Cyclosporine
Steroids
Rapamune (Sirolimus)
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Kidney, Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome 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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
March 13, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00167947
Brief Title
Study Evaluating Sirolimus in Kidney Transplant Recipients.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Renal function at 12 months assessed by calculated creatinine clearance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Graft vs Host Disease
Keywords
Kidney, Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
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 "
Intervention Type
Drug
Intervention Name(s)
Steroids
Intervention Description
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 "
Intervention Type
Drug
Intervention Name(s)
Rapamune (Sirolimus)
Intervention Description
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 "
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Italy, decresg@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Palermo
State/Province
Sicily
ZIP/Postal Code
90127
Country
Italy
City
Bari
ZIP/Postal Code
70100
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Cagliari
ZIP/Postal Code
09125
Country
Italy
City
Firenze
ZIP/Postal Code
50139
Country
Italy
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Pisa
ZIP/Postal Code
56100
Country
Italy
City
Sassari
ZIP/Postal Code
07100
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Udine
ZIP/Postal Code
37100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

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Study Evaluating Sirolimus in Kidney Transplant Recipients.

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