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Prediction of Medication Compliance Following Renal Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148187
First Posted: September 7, 2005
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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 ]
    Prediction of declining medication adherence during first three months post kidney transplantation.


Enrollment: 30
Study Start Date: January 2003
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148187


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00148187     History of Changes
Other Study ID Numbers: 0202M17442
2P01DK013083-40A1 ( U.S. NIH Grant/Contract )
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: June 1, 2015
Last Verified: May 2015

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