NCT00148174

Brief Summary

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss. Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 1998

Longer than P75 for not_applicable

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

August 1, 1998

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

16.3 years

First QC Date

September 2, 2005

Last Update Submit

May 28, 2015

Conditions

Kidney Transplantation

Keywords

Medication adherencePatient complianceKidney transplantOrgan rejectionAllograft lossDrug monitoring

Outcome Measures

Primary Outcomes (1)

  • Graft loss

    prospective

Secondary Outcomes (2)

  • Acute rejection

    prospective

  • Death

    prospective

Study Arms (1)

Phone calling

EXPERIMENTAL

Phone calling to encourage improved adherence

Behavioral: Intensive telephone followup

Interventions

Intensive telephone followupBEHAVIORAL

Telephone calling

Phone calling

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant
  • Discharged from hospital with functioning graft

You may not qualify if:

  • Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
  • Patients with active psychosis
  • Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
  • Patients taking the liquid form of azathioprine or mycophenolate mofetil
  • Patients who are younger than 14 yrs. old
  • Patients who do not speak English
  • Receiving extra-renal organ except for pancreas,either simultaneously or previously
  • Patients who live and will be followed outside of the United States, except Canada
  • Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
  • Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Medication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Thomas E Nevins, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

August 1, 1998

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)