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OpenTrials
Completed

NCT Number: NCT00148187

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prediction of early medication adherence

    Time frame: 3 months

    Prediction of declining medication adherence during first three months post kidney transplantation.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2005
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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