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

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.

Study Overview

• Status: Unknown
• Conditions: Adherence to Medication Regime
• Intervention / Treatment: Drug: Advagraf; Drug: Prograf

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chin-Yuan Lee; Phone Number: +886-972651446; Email: gs2119@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advagraf; Take Advagraf once daily	Drug: Advagraf; Compare the drug compliance between once daily or twice daily regimen; Other Names: Advagraf once daily
Active Comparator: Prograf; Take tacrolimus twice daily	Drug: Prograf; Compare the drug compliance between once daily or twice daily regimen; Other Names: Prograf twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Astellas Pharma Taiwan, Inc.
• Investigators: Principal Investigator: Chin-Yuan Lee, hospital medical school affiliations

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2014
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: June 15, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 31, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Compliance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 201401105MIPA