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Natural History Study of Azathioprine Adherence

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ClinicalTrials.gov Identifier: NCT00143910
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )

Brief Summary:
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 or disease Intervention/treatment
Kidney 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

Study Type : Observational
Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Compliance in Renal Transplant Recipients
Study Start Date : April 1993
Actual Primary Completion Date : October 1999
Actual Study Completion Date : October 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Renal transplant recipient
Recipients of successful renal transplant
Other: observation



Primary Outcome Measures :
  1. acute transplant rejection [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Allograft loss [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications of Results:
Responsible Party: Thomas E. Nivens, MD
ClinicalTrials.gov Identifier: NCT00143910     History of Changes
Other Study ID Numbers: 9109M04306
NIH - DK13083
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD ):
Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring