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Natural History Study of Azathioprine Adherence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143910
First Posted: September 2, 2005
Last Update Posted: December 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Thomas E. Nivens, MD )
September 1, 2005
September 2, 2005
December 6, 2013
April 1993
October 1999   (Final data collection date for primary outcome measure)
acute transplant rejection [ Time Frame: 10 years ]
Not Provided
Complete list of historical versions of study NCT00143910 on ClinicalTrials.gov Archive Site
Allograft loss [ Time Frame: 10 years ]
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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00143910
9109M04306
NIH - DK13083
No
Not Provided
Not Provided
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