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Predictors and Intervention for Noncompliance | Clinical Trials | Clareo Health

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COMPLETEDNANCT00148174

Predictors and Intervention for Noncompliance

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 stu...

Lead sponsor: University of Minnesota•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Minnesota

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Kidney transplant
•Discharged from hospital with functioning graft

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 1, 2015Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment273

Start dateAug 1998

Last updatedJun 1, 2015

Condition

Kidney Transplantation

Locations shown

University of Minnesota

Minneapolis, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2015Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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