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
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
|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 September 30, 2014