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Immunosuppressant Medication Dosed Daily After Kidney Transplant

NCT04156204 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-12-02

No results posted yet for this study

Summary

Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.

Conditions

  • Kidney Transplant Rejection
  • Medication Adherence

Interventions

OTHER

Medication Event Monitoring System (MEMS)

AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system

DRUG

Once-Daily Tacrolimus extended release

AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jens Goebel, MD · Children's Hospital Colorado

  • Mary Chandran, MD · Children's Hospital Colorado

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2020-11-27
Completion
2020-11-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156204 on ClinicalTrials.gov