Prediction of Medication Compliance Following Renal Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00148187
First received: September 2, 2005
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition
Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Medication Compliance Following Renal Transplantation

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Prediction of early medication adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Prediction of declining medication adherence during first three months post kidney transplantation.


Estimated Enrollment: 60
Study Start Date: January 2003
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pre-operative renal transplant recipients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148187

Contacts
Contact: Thomas E Nevins, MD 612-626-2922 nevin001@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Thomas E Nevins, MD    612-626-2922    nevin001@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00148187     History of Changes
Other Study ID Numbers: 0202M17442, 2P01DK013083-40A1
Study First Received: September 2, 2005
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring

ClinicalTrials.gov processed this record on July 28, 2014