Prediction of Medication Compliance Following Renal Transplantation

NCT ID: NCT00148187

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Kidney Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E Nevins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2P01DK013083-40A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0202M17442

Identifier Type: -

Identifier Source: org_study_id