A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: Prograf (Drug); Advagraf (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Korea, Inc. Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Astellas Pharma Korea, Inc.
Summary
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in glomerular filtration rate (GFR) at Week 24 from baseline
Secondary outcome: Change in Blood Pressure (BP) at Week 24 from baselineChange in HbA1c at Week 24 from baseline Change in tacrolimus blood trough level at Week 24 from baseline Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests Overall frequency of acute rejection
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Seoul, Korea, Republic of
Additional Information
Starting date: September 2010
Last updated: April 30, 2013
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