NCT00195468

Brief Summary

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2004

Typical duration for phase_4

Geographic Reach
2 countries

13 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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 8, 2011

Status Verified

December 1, 2007

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

March 7, 2011

Conditions

Kidney FailureGraft vs Host Disease

Keywords

Kidney FailureTransplant

Outcome Measures

Primary Outcomes (1)

  • Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

Secondary Outcomes (1)

  • Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.

Interventions

CYCLOSPORINEDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

You may not qualify if:

  • Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Curitiba, Paraná, 80730-150, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Unknown Facility

Ribeirao Preto, Rio Grande do Sul, 14048-900, Brazil

Location

Unknown Facility

São José do Rio Preto, São Paulo, 15015-200, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01323-001, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04038-002, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 05403-000, Brazil

Location

Unknown Facility

Chihuahua City, Chihuahua, Mexico

Location

Unknown Facility

Torreón, Coahuila, 27000, Mexico

Location

Unknown Facility

Mexico City DF, 14000, Mexico

Location

MeSH Terms

Conditions

Renal InsufficiencyGraft vs Host Disease

Interventions

Cyclosporine

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 Proteins

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Brazil, xavierl@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Mexico, gomezlj@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

March 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

March 8, 2011

Record last verified: 2007-12

Locations

ME(3)BR(10)