Natural History Study of Azathioprine Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
ClinicalTrials.gov Identifier:
NCT00143910
First received: September 1, 2005
Last updated: December 5, 2013
Last verified: December 2013

September 1, 2005
December 5, 2013
April 1993
October 1999   (final data collection date for primary outcome measure)
acute transplant rejection [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00143910 on ClinicalTrials.gov Archive Site
Allograft loss [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Natural History Study of Azathioprine Adherence
Measurement of Compliance in Renal Transplant Recipients

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.

  • 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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Kidney Transplant
Other: observation
Renal transplant recipient
Recipients of successful renal transplant
Intervention: Other: observation
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.
 
Completed
180
October 1999
October 1999   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00143910
9109M04306, NIH - DK13083
No
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
Thomas E. Nivens, MD
Not Provided
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
December 2013

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