NCT00419575

Brief Summary

The aim of this observational study is to evaluate an FDA approved immune system monitoring assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard immunosuppression and prophylaxis protocols from the time of transplantation through a twelve month follow-up period. The primary endpoint will be the incidence of acute rejection and infection and any correlation of these events to an assay that may be a measure of recipient immune response. Secondary endpoints will include evaluation of renal function, patient and graft survival, incidence of post-transplantation lymphoproliferative disorder and duration and extent of lymphocyte depletion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

First QC Date

January 5, 2007

Last Update Submit

June 4, 2008

Conditions

Renal TransplantationImmunosuppression

Keywords

renaltransplantationimmunosuppressionmonitoring

Eligibility Criteria

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

Kidney transplant recipients.

You may qualify if:

  • All consenting adult renal transplant recipients (age 18 years of age or older)
  • Females of childbearing age must have a negative pregnancy test performed at the time of admission for transplantation
  • Patient or guardian agrees to participate in the study and signs the informed consent.
  • Patients already consented to another study, if allowed by the study sponsor and PI of that study.

You may not qualify if:

  • Pregnant women or nursing mothers
  • Any patient who, in the opinion of the investigator, has a significant medical or psychosocial problem that should preclude them from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Matthew J Koch, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

October 1, 2006

Study Completion

May 1, 2008

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

US(1)