A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF (PeACE)

A Multicenter, Open-label, Single-arm, Non-inferiority Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF® in Stable Kidney Transplant Patients Converted From a PROGRAF® Based Immunosuppressive Regimen

The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Prograf; Drug: Advagraf

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients received a kidney transplant at least 12 months ago prior to enrollment.
2. Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
3. Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
4. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
5. Patients are considered clinically stable by observer's judgment.
6. Patients must understand the purpose and risk of participating the trial and signed on the written consent.

Exclusion Criteria:

1. Patients have previously received an organ transplant other than a kidney.
2. Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
3. Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
4. Patients have a known hypersensitivity to Prograf® or tacrolimus.
5. Patients whose medical condition are able to interfere with the study objectives.
6. Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer.
7. Patients have been participated in another clinical trial, or treated with drugs of clinical trial within 28 days prior to enrollment.
8. Patients have been taken prohibited combination agents within 28 days prior to enrollment.
9. Patients are pregnant or lactating.
10. Patient are HIV-positive.
11. Patients are not able to keep the scheduled visit.
12. Patients whose GFR (MDRD) is in the level of <30 mL/min.
13. Patients who are at the condition of 'Creeping creatinine (defined by 20% increase within 6 months prior to enrollment)
14. Patients whose SGPT/AST and/or SGOT/ALT levels have been elevated greater than 2 times the upper value of the normal range.
15. Patients have FSGS or MPGN Type II as underlying diseases.
16. Patients are with cirrhosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prograf/Advagraf; conversion from Prograf to Advagraf	Drug: Prograf; oral; Other Names: FK506; tacrolimus; Drug: Advagraf; oral; Other Names: FK506E; tacrolimus modified release formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in glomerular filtration rate (GFR) at Week 24 from baseline	Baseline and Week-24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Blood Pressure (BP) at Week 24 from baseline	Baseline and Week-24
Change in HbA1c at Week 24 from baseline	Baseline and Week-24
Change in tacrolimus blood trough level at Week 24 from baseline	Baseline and Week-24
Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests	For 24 weeks
Overall frequency of acute rejection	For 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (ESTIMATE): April 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: immunosuppressant; FK506; tacrolimus
• 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: ADV-KT-02