NCT00729248

Brief Summary

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive therapy to promote a regulatory profile and determining possibly newer accepted dosing and drug concentrations for agents most associated with this regulatory profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 28, 2013

Completed
Last Updated

August 28, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

August 4, 2008

Results QC Date

August 25, 2010

Last Update Submit

May 23, 2013

Conditions

ImmunosuppressionKidney Transplantation

Keywords

TransplantsKidney TransplantationImmunosuppressionAssayGraft Rejection

Outcome Measures

Primary Outcomes (1)

  • CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors

    CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and \> 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and \> 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Six to Twelve preoperative renal transplant living donor pairs.

You may qualify if:

  • Adults 18 years of Age or Older
  • Undergoing living donor renal transplant

You may not qualify if:

  • No active infection or history of malignancy
  • No HIV infection
  • No Hepatitis C (HCV) infection
  • No prior transplant (kidney or other organ)
  • No chromic use of immunosuppressive therapy or history of autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

White Cells.

Results Point of Contact

Title
Lorenzo Gallon, MD - Study Principal Investigator
Organization
Northwestern University
l-gallon@northwestern.edu
312-695-4457

Study Officials

  • Lorenzo Gallon, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

January 1, 2010

Last Updated

August 28, 2013

Results First Posted

August 28, 2013

Record last verified: 2013-05

Locations

US(1)