Prediction of Medication Compliance Following Renal Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00148187

Enrollment

Registered

2005-09-07

Start date

2003-01-31

Completion date

2014-11-30

Last updated

2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results