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NCT00143910 Clinical Trial

Natural History Study of Azathioprine Adherence

Kidney Transplant Clinical Trial

Official title:
Measurement of Compliance in Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143910
Other study ID # 9109M04306
Secondary ID NIH - DK13083
Status Completed
Phase
First received
Last updated
Start date April 1993
Est. completion date October 1999

Study information
Verified date October 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date October 1999
Est. primary completion date October 1999
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• observation

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Thomas E. Nivens, MD

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary acute transplant rejection 10 years
Secondary Allograft loss 10 years
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