Completed
PeACEA 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
What is being tested
Prograf
+ Advagraf
Drug
Who is being recruted
Over 20 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: September 2010
Summary
Principal SponsorAstellas Pharma Korea, Inc.
Last updated: May 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2010
Actual date on which the first participant was enrolled.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.
Principal SponsorAstellas Pharma Korea, Inc.
Last updated: May 1, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
138 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
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
Patients are considered clinically stable by observer's judgment
Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment
Patients have taken unchanged dosage of Prograf and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment
Show More Criteria
16 exclusion criteria prevent from participating
Patient are HIV-positive
Patients are not able to keep the scheduled visit
Patients are pregnant or lactating
Patients are with cirrhosis
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentalconversion from Prograf to Advagraf
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Completed4 Study Centers