Renal Transplantation With Immune Monitoring

Completed

Conditions studied: Renal Transplantation, Immunosuppression

In brief

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.

Key facts

Study ID

NCT00419575

Run by

Washington University School of Medicine

People needed

60

Starts

2006-10-01

Expected to finish

2008-05-01

Last updated by the study team

2008-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Washington University School of Medicine/Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.