Natural History Study of Azathioprine Adherence

Completed

• Conditions: Kidney Transplant

• Registration Number: NCT00143910
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1993-04
• Primary Completion: 1999-10
• Study Completion: 1999-10
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute transplant rejection	10 years

Secondary Outcome Measures

Name	Time	Method
Allograft loss	10 years

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States