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Status unknownNCT02251691Updated Apr 2, 2019

Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant

A Phase 4 interventional study of Advagraf and Prograf in Adherence to Medication Regime, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

This study will be a prospective, two-arm randomized and open-label, phase IV study to compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus standard twice-daily tacrolimus based regimen after de novo renal transplantation.

The investigators 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)

02

Conditions studied

  • Adherence to Medication Regime

Keywords

  • Compliance
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Male and female adult patients who are to receive renal transplantation may enter the study. The intention is to enroll 90 patients who have fulfilled inclusion/exclusion criteria into the study. Sixty patients will receive prolonged-release once-daily tacrolimus based therapy; the other thirty patients will receive standard twice-daily tacrolimus based therapy.

Inclusion criteria

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
  • Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to comply fully with the study requirements.
  • Patients who require on-going dosing with a systemic immunosuppressive drugs prior to transplantation.
  • Pregnant woman or breast-feeding mother during the period of this study.
  • Patients who are allergy to tacrolimus, macrolide antibiotics, steroid or mycophenolate mofetil.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Advagraf

    Take Advagraf once daily

    Drug: Advagraf

  • Active comparator
    Prograf

    Take tacrolimus twice daily

    Drug: Prograf

Interventions

  • DrugAdvagraf

    Compare the drug compliance between once daily or twice daily regimen

    Also known as: Advagraf once daily

  • DrugPrograf

    Compare the drug compliance between once daily or twice daily regimen

    Also known as: Prograf twice daily

06

What researchers measure

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)

    Time frame: 12 months

Secondary outcomes

  1. serum creatinine level

    We will evaluate the serum creatinine level of the patients enrolled in this study.

    Time frame: 12 months

  2. graft survival

    We will evaluate the graft survival of the patients enrolled in this study.

    Time frame: 12 months

  3. patient survival

    We will evaluate the patient survival of the patients enrolled in this study.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36094829 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02251691
Lead sponsor
National Taiwan University Hospital
Collaborators
Astellas Pharma Taiwan, Inc.
Responsible party
Sponsor
First posted
Sep 29, 2014
Start date
May 9, 2014
Primary completion
Mar 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Apr 2, 2019

Study contacts

Chin-Yuan Lee
Contact
gs2119@gmail.com
+886-972651446
Chin-Yuan Lee
principal investigator · hospital medical school affiliations

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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