Status:
COMPLETED
Predictors and Intervention for Noncompliance
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Kidney Transplantation
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 te...
Eligibility Criteria
Inclusion
- Kidney transplant
- Discharged from hospital with functioning graft
Exclusion
- 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
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00148174
Start Date
August 1 1998
End Date
December 1 2014
Last Update
June 1 2015
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455