NCT00143910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 1993

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1993

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1999

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

6.5 years

First QC Date

September 1, 2005

Last Update Submit

October 2, 2023

Conditions

Kidney Transplant

Keywords

Medication adherencePatient complianceKidney transplantOrgan rejectionAllograft lossDrug monitoring

Outcome Measures

Primary Outcomes (1)

  • acute transplant rejection

    10 years

Secondary Outcomes (1)

  • Allograft loss

    10 years

Study Arms (1)

Renal transplant recipient

Recipients of successful renal transplant

Other: observation

Interventions

observationOTHER
Renal transplant recipient

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Kidney transplant recipient
  • Discharged from hospital with functioning graft,not on dialysis
  • Prescribed azathioprine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related 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.

    PMID: 11576374RESULT

MeSH Terms

Conditions

Medication AdherencePatient Compliance

Interventions

Observation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Thomas E Nevins, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

April 1, 1993

Primary Completion

October 1, 1999

Study Completion

October 1, 1999

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

US(1)