NCT02805842

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

May 8, 2016

Last Update Submit

July 10, 2016

Conditions

Medication Adherence

Keywords

non adherenceTacrolimusAdvagraf

Outcome Measures

Primary Outcomes (1)

  • Morisky Medical Adherence Assessment questionnaire

    adherence to the Tacrolimus QD administration defined as self-reported number 9on scale from 1-8) of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire

    2 years

Secondary Outcomes (3)

  • graft and patient survival

    2 years

  • gfr

    2 years

  • adverse events

    2years

Study Arms (2)

Tacrolimus BID

ACTIVE COMPARATOR

20 patients receiving twice daily (BID) Tacrolimus

Drug: Tacrolimus BID

Advagraf QD

ACTIVE COMPARATOR

40 patients randomized to receive once daily (QD) Advagraf

Drug: Advagraf QD

Interventions

Tacrolimus BIDDRUG

Administration of Tacrolimus BID

Also known as: Prograf, Tacrocell
Tacrolimus BID
Advagraf QDDRUG

administration of Advagraf QD

Also known as: Advagraf
Advagraf QD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 Years to 60 Years
  • Gender: both
  • Patients willing and able to participate in this study
  • Patients who signed the informed consent form
  • Patients who can visit the center based on the study schedule in the protocol

You may not qualify if:

  • Patients who had previously received a kidney or another organ
  • Patients, having positive lymphocyte cross-match
  • Patients with PRA \>50%
  • Patients, who underwent desensitization
  • Patients, who were diagnosed with cancer in the last five years
  • Patients, who themselves or their donors have positive HIV, HBsAg, or anti-HCV test results
  • Patients, who were treated with other investigated drugs within 30 days from their study enrollment
  • Patients, who are planning to be pregnant, or who are pregnant or breastfeeding and who are not planning to use any contraceptive method during the study period.
  • Patients who were addicted to drugs/alcohol within six months of their study enrollment
  • Patients, who have a mental illness that makes appropriate communication with them impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Med Ctr

Petah Tikva, Israel, 4100, Israel

Location

Related Publications (1)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Eyan Mor, MD

    Rabin Med CTR

    STUDY DIRECTOR

Central Study Contacts

Eytan Mor, MD

CONTACT

97239376472emor@clalit.org.il

Alex Yussim, MD

CONTACT

97239376479ayussim@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director transplantation research unit

Study Record Dates

First Submitted

May 8, 2016

First Posted

June 20, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)