Predictors and Intervention for Noncompliance

Kidney Transplantation Clinical Trial

Official title:

Predictors and Intervention for Noncompliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148174
• Other study ID #: 9611M11943
• Secondary ID: 2P01DK013083-40A
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: May 28, 2015
• Start date: August 1998
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Behavioral:
• Intensive telephone followup
Telephone calling

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft loss		prospective	No
Secondary	Acute rejection		prospective	No
Secondary	Death		prospective	No