Natural History Study of Azathioprine Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
ClinicalTrials.gov Identifier:
NCT00143910
First received: September 1, 2005
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.


Condition Intervention
Kidney Transplant
Other: observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Compliance in Renal Transplant Recipients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • acute transplant rejection [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allograft loss [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 1993
Study Completion Date: October 1999
Primary Completion Date: October 1999 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Renal transplant recipient
Recipients of successful renal transplant
Other: observation

Detailed Description:
  • The study is complete. Patient recruitment is closed and active patient involvement in the study has ended.
  • Statistical analysis of monitor records and new patient outcome data continues
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.

Criteria

Inclusion Criteria:

  • Kidney transplant recipient
  • Discharged from hospital with functioning graft,not on dialysis
  • Prescribed azathioprine

Exclusion Criteria:

  • Unable to give informed consent
  • Non English speaking
  • Previous or concurrent organ transplant other than kidney
  • Taking liquid form of azathioprine
  • Followed outside of the United states
  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: NCT00143910

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Thomas E. Nivens, MD
Investigators
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
ClinicalTrials.gov Identifier: NCT00143910     History of Changes
Other Study ID Numbers: 9109M04306, NIH - DK13083
Study First Received: September 1, 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 September 22, 2014