Natural History Study of Azathioprine Adherence

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Thomas E. Nevins, University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT00143910

First received: September 1, 2005

Last updated: May 17, 2013

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

May 17, 2013

Start Date ^ICMJE

April 1993

Primary Completion Date

October 1999 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

acute transplant rejection [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00143910 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Allograft loss [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Natural History Study of Azathioprine Adherence

Official Title ^ICMJE

Measurement of Compliance in Renal Transplant Recipients

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.

Condition ^ICMJE

Kidney Transplant

Intervention ^ICMJE

Other: observation

Study Group/Cohort (s)

Renal transplant recipient

Recipients of successful renal transplant

Intervention: Other: observation

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

October 1999

Primary Completion Date

October 1999 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00143910

Other Study ID Numbers ^ICMJE

9109M04306, NIH - DK13083

Has Data Monitoring Committee

Responsible Party

Thomas E. Nevins, University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

Thomas E. Nivens, MD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas E Nevins, MD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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