NCT00240214

Brief Summary

The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

6.8 years

First QC Date

October 13, 2005

Last Update Submit

March 13, 2008

Conditions

Renal Transplantation

Keywords

Kidney transplants

Study Arms (1)

1

sirolimus

Drug: sirolimus

Interventions

sirolimusDRUG

Tablet, dosage is determined by trough level

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.

You may not qualify if:

  • Contraindications according to Summary of the Product Characteristics (SmPC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Cities, Germany

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Germany, medinfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

April 1, 2001

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

DE(1)