NCT02251691

Brief Summary

The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen. The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation recipients base on the assumption that once-daily dosing regimen may help to improve drug compliance.

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

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

Study Start

First participant enrolled

May 9, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 15, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

5.9 years

First QC Date

June 15, 2014

Last Update Submit

March 31, 2019

Conditions

Adherence to Medication Regime

Keywords

Compliance

Outcome Measures

Primary Outcomes (1)

  • basal assessment of adherence with immunosuppressive medication scale

    We will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)

    12 months

Secondary Outcomes (3)

  • serum creatinine level

    12 months

  • graft survival

    12 months

  • patient survival

    12 months

Study Arms (2)

Advagraf

EXPERIMENTAL

Take Advagraf once daily

Drug: Advagraf

Prograf

ACTIVE COMPARATOR

Take tacrolimus twice daily

Drug: Prograf

Interventions

AdvagrafDRUG

Compare the drug compliance between once daily or twice daily regimen

Also known as: Advagraf once daily
Advagraf
PrografDRUG

Compare the drug compliance between once daily or twice daily regimen

Also known as: Prograf twice daily
Prograf

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Male or female patients at 20-65 years of age undergoing renal transplantation
  • Patients who have been informed of the potential risks and side effects of the study
  • Female patients of childbearing potential must agree to maintain effective birth control during the study.
  • Patients have been fully informed and have given written informed consent to participate in the study
  • Donor age greater than 65 years
  • Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)
  • Patients who are recipients of multiple solid organ transplants
  • Patients undergoing second or subsequent transplantation
  • Patients with pre-transplant PRA \> 20%
  • Patients with ABO incompatibility or positive lymphocytotoxicity
  • Patients with severe, active infection
  • Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or total bilirubin \>3 times the upper normal limit
  • Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive
  • Patients who have been treated with an investigational drug or therapy within one month prior to entry or who will be so treated within 6 months of transplantation
  • Patients with a history of malignancy within the last five years except excised squamous or basal cell carcinoma
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

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 AdherencePatient Compliance

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Chin-Yuan Lee

    hospital medical school affiliations

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Yuan Lee

CONTACT

+886-972651446gs2119@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2014

First Posted

September 29, 2014

Study Start

May 9, 2014

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

TW(1)