Natural History Study of Azathioprine Adherence

Completed

• Conditions: Kidney Transplant
• Interventions: Other: observation

• 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

Arm && Interventions

Group	Intervention	Description
Renal transplant recipient	observation	Recipients of successful renal transplant

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