Prediction of Medication Compliance Following Renal Transplantation

Kidney Transplantation Clinical Trial

Official title:

Prediction of Medication Compliance Following Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148187
• Other study ID #: 0202M17442
• Secondary ID: 2P01DK013083-40A
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: May 28, 2015
• Start date: January 2003
• Est. completion date: November 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: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

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	Prediction of early medication adherence	Prediction of declining medication adherence during first three months post kidney transplantation.	3 months	No