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Natural History Study of Azathioprine Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas E. Nevins, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00143910
First received: September 1, 2005
Last updated: May 17, 2013
Last verified: September 2005
History of Changes
  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:

U.S. FDA Resources

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
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: Thomas E. Nevins, MD, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00143910     History of Changes
Other Study ID Numbers: 9109M04306, NIH - DK13083
Study First Received: September 1, 2005
Last Updated: May 17, 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 June 18, 2013