Predictors and Intervention for Noncompliance

Completed · Not applicable

Conditions studied: Kidney Transplantation

In brief

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss. Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Key facts

Study ID

NCT00148174

Run by

University of Minnesota

People needed

273

Starts

1998-08-01

Expected to finish

2014-12-01

Last updated by the study team

2015-06-01

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney transplant
• Discharged from hospital with functioning graft

You may not qualify if…

• Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
• Patients with active psychosis
• Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
• Patients taking the liquid form of azathioprine or mycophenolate mofetil
• Patients who are younger than 14 yrs. old
• Patients who do not speak English
• Receiving extra-renal organ except for pancreas,either simultaneously or previously
• Patients who live and will be followed outside of the United States, except Canada
• Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
• Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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