Natural History Study of Azathioprine Adherence | NCT00143910

Studies
Natural History Study of Azathioprine Adherence

NCT00143910

Sponsor

Thomas E. Nivens, MD

Status

Completed

Last Update Posted

Oct 4, 2023Actual

Enrollment

180

Phase

Not provided

Conditions

Kidney Transplant

Interventions

observation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIH - DK13083

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1993

Primary Completion Date

Oct 1999Actual

Completion Date

Oct 1999Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2023

Last Update Posted Date

Oct 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal transplant recipient		Recipients of successful renal transplant	Other: observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other		Renal transplant recipient

Measure	Description	Time Frame
acute transplant rejection		10 years

Measure	Description	Time Frame
Allograft loss		10 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas E Nevins, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11576374	Result	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.

ID	Term
D055118	Medication Adherence
D010349	Patient Compliance

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
D008722	Methods
D008919	Investigative Techniques