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Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus

NCT02805842 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-12

No results posted yet for this study

Summary

Aim The primary objective of this study is to compare medication adherence with medical therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.

Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and once-daily tacrolimus groups

Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily regimens, measured in terms of implementation. Secondary outcomes will include graft and patient survival, renal function and adverse events. Follow up - 12 months

Conditions

  • Medication Adherence

Interventions

DRUG

Tacrolimus BID

Administration of Tacrolimus BID

DRUG

Advagraf QD

administration of Advagraf QD

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Teva Pharma

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Eyan Mor, MD · Rabin Med CTR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Israel

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 NCT02805842 on ClinicalTrials.gov