NCT00195195

Brief Summary

The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

3 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 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

January 26, 2012

Conditions

Transplantation

Keywords

Transplantation

Study Arms (1)

1

Sirolimus

Drug: Sirolimus

Interventions

SirolimusDRUG

Transplantation patients treated with sirolimus who consent to participate in the study (register)

Also known as: Rapamune
1

Eligibility Criteria

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

Transplantation patients treated with sirolimus.

You may qualify if:

  • Transplantation patients treated with sirolimus (Rapamune).

You may not qualify if:

  • Patients must be able to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Gothenburg, SE-413 45, Sweden

Location

Unknown Facility

Stockholm, SE-141 86, Sweden

Location

Unknown Facility

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

SE(3)