NCT02251691

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Adherence to Medication Regime

Interventions

Type	Name	Description
DRUG	Advagraf	Compare the drug compliance between once daily or twice daily regimen
DRUG	Prograf	Compare the drug compliance between once daily or twice daily regimen

Timeline

• Start date: 2014-05-09
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2014-09-29
• Last updated: 2019-04-02

Locations

1 site across 1 country: Taiwan