Natural History Study of Azathioprine Adherence

NCT ID: NCT00143910

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-04-30

Study Completion Date

1999-10-31

Brief Summary

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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

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* 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

Conditions

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal transplant recipient

Recipients of successful renal transplant

observation

Intervention Type OTHER

Interventions

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observation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas E. Nivens, MD

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas E Nevins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001 Oct;60(4):1565-70. doi: 10.1046/j.1523-1755.2001.00961.x.

Reference Type RESULT
PMID: 11576374 (View on PubMed)

Other Identifiers

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NIH - DK13083

Identifier Type: -

Identifier Source: secondary_id

9109M04306

Identifier Type: -

Identifier Source: org_study_id

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