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

Adherence to Medication Regime Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02251691
• Other study ID #: 201401105MIPA
• Status: Recruiting
• Phase: Phase 4
• Start date: May 9, 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2019
• Source: National Taiwan University Hospital
• Contact: Chin-Yuan Lee
• Phone: +886-972651446
• Email: gs2119[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence to Medication Regime

Intervention

Drug:
• Advagraf
Compare the drug compliance between once daily or twice daily regimen
• Prograf
Compare the drug compliance between once daily or twice daily regimen

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

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