NCT00167947

Brief Summary

Renal function at 12 months assessed by calculated creatinine clearance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

2.5 years

First QC Date

September 9, 2005

Last Update Submit

March 13, 2008

Conditions

Kidney FailureGraft vs Host Disease

Keywords

KidneyTransplant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: CyclosporineDrug: SteroidsDrug: Rapamune (Sirolimus)

B

EXPERIMENTAL
Drug: CyclosporineDrug: SteroidsDrug: Rapamune (Sirolimus)

Interventions

CyclosporineDRUG

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 "

AB
SteroidsDRUG

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 "

AB
Rapamune (Sirolimus)DRUG

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 "

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Rome, Lazio, 00144, Italy

Location

Unknown Facility

Rome, Lazio, 00168, Italy

Location

Unknown Facility

Palermo, Sicily, 90127, Italy

Location

Unknown Facility

Bari, 70100, Italy

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Cagliari, 09125, Italy

Location

Unknown Facility

Florence, 50139, Italy

Location

Unknown Facility

L’Aquila, 67100, Italy

Location

Unknown Facility

Milan, 20162, Italy

Location

Unknown Facility

Pisa, 56100, Italy

Location

Unknown Facility

Sassari, 07100, Italy

Location

Unknown Facility

Siena, 53100, Italy

Location

Unknown Facility

Udine, 37100, Italy

Location

Unknown Facility

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Renal InsufficiencyGraft vs Host Disease

Interventions

CyclosporineSteroidsSirolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsFused-Ring CompoundsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Italy, decresg@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

IT(14)