Prediction of Medication Compliance Following Renal Transplantation

The purpose of this study is to quantitate pre-transplant medication compliance, dialysis compliance, and related psychological variables, and then examine their validity as predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute rejection, graft loss, or death).

Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription, and specific psychological variables predict similarly noncompliant behaviors after transplantation.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation

Detailed Description

This pilot study is intended to provide preliminary data about the feasibility of recruiting a cohort of subjects on hemodialysis and following them prospectively through the transplant procedure. The study will document patient adherence to medications and treatment, both before and after surgery. These preliminary data will permit appropriate design and power calculations for a future study assessing our ability to predict post-transplant compliance, based on pre-transplant behaviors.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pre-operative renal transplant recipients

Description

Inclusion Criteria:

• Adult hemodialysis patients in renal transplant evaluation
• Able to read test forms
• Responsible for their own medications

Exclusion Criteria:

• Patients with a major 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 who do not speak English.
• Patients who live and will be followed outside 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.
• Patients who are younger than 14 years old
• Patients who will receive an extra renal organ (except pancreas), either simultaneously or previously.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of early medication adherence	Prediction of declining medication adherence during first three months post kidney transplantation.	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 7, 2005

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Medication adherence; Kidney transplant; Organ rejection; Patient compliance; Drug monitoring; Allograft loss
• Other Study ID Numbers: 0202M17442; 2P01DK013083-40A1 (U.S. NIH Grant/Contract)