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

Phase 4

• Conditions: Adherence to Medication Regime
• Interventions: Drug: Advagraf; Drug: Prograf

• Registration Number: NCT02251691
• Lead Sponsor: National Taiwan University Hospital

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)

Study Timeline

• Study Start: 2014-05-09
• Study First Submitted: 2014-06-15
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-31
• Last Update Posted: 2019-04-02
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advagraf	Advagraf	Take Advagraf once daily
Prograf	Prograf	Take tacrolimus twice daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan