NCT00842699

Brief Summary

The goal of the study is to find out the effects of two different drugs used at the beginning of organ transplantation on different populations of immune cells in the body of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

February 10, 2009

Last Update Submit

June 27, 2011

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is to look for expansion of regulatory T cells at one year.

    12 months

Study Arms (2)

1

patients receiving IL-2 receptor antagonist (Simulect) as induction treatment

2

patients receiving Thymoglobulin as induction treatment

Eligibility Criteria

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

renal transplant recipients and living donors if available

You may qualify if:

  • all patients considered for transplantation

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Nader Najafian, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

US(1)