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

The Influence of Once-daily Versus Twice-daily Immunosuppressive Regimen on Drug Compliance in Patients After Renal Transplantation

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02251691

Enrollment

Registered

2014-09-29

Start date

2014-05-09

Completion date

2020-03-31

Last updated

2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to Medication Regime

Keywords

Compliance

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.

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)

Interventions

DRUGAdvagraf

Compare the drug compliance between once daily or twice daily regimen

DRUGPrograf

Compare the drug compliance between once daily or twice daily regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
basal assessment of adherence with immunosuppressive medication scale	12 months	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)

Secondary

Measure	Time frame	Description
serum creatinine level	12 months	We will evaluate the serum creatinine level of the patients enrolled in this study.
graft survival	12 months	We will evaluate the graft survival of the patients enrolled in this study.
patient survival	12 months	We will evaluate the patient survival of the patients enrolled in this study.

Countries

Taiwan

Contacts

Primary ContactChin-Yuan Lee

gs2119@gmail.com+886-972651446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026