Natural History Study of Azathioprine Adherence
October 2, 2023 updated by: Thomas E. Nivens, MD
Measurement of Compliance in Renal Transplant Recipients
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.
Study Overview
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Renal transplant recipient
Recipients of successful renal transplant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
acute transplant rejection
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Allograft loss
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas E Nevins, MD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 1993
Primary Completion (Actual)
October 1, 1999
Study Completion (Actual)
October 1, 1999
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimated)
September 2, 2005
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9109M04306
- NIH - DK13083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.