Natural History Study of Azathioprine Adherence
This study has been completed.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
First received: September 1, 2005
Last updated: December 5, 2013
Last verified: December 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Measurement of Compliance in Renal Transplant Recipients
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 1999 (Final data collection date for primary outcome measure)
Renal transplant recipient
Recipients of successful renal transplant
- 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
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.
- Kidney transplant recipient
- Discharged from hospital with functioning graft,not on dialysis
- Prescribed azathioprine
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00143910
|University of Minnesota
|Minneapolis, Minnesota, United States, 55455 |
Thomas E. Nivens, MD
||Thomas E Nevins, MD
||University of Minnesota - Clinical and Translational Science Institute
||University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
History of Changes
|Other Study ID Numbers:
||9109M04306, NIH - DK13083
|Study First Received:
||September 1, 2005
||December 5, 2013
||United States: Institutional Review Board
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
ClinicalTrials.gov processed this record on February 27, 2015