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

NCT01839929 | Completed Phase 4

• 1 other identifier: ADV-KT-02
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Kidney Transplantation

Keywords

tacrolimus; immunosuppressant; FK506

Outcome Measures

Primary Outcomes (1)

• Change in glomerular filtration rate (GFR) at Week 24 from baseline

  Baseline and Week-24

Secondary Outcomes (5)

• 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

Study Arms (1)

Prograf/Advagraf

EXPERIMENTAL

conversion from Prograf to Advagraf

Drug: Prograf; Drug: Advagraf

Interventions

Prograf DRUG

oral

Also known as: FK506, tacrolimus

Prograf/Advagraf

Advagraf DRUG

oral

Also known as: FK506E, tacrolimus modified release formulation

Prograf/Advagraf

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients received a kidney transplant at least 12 months ago 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.
• Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
• 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 must understand the purpose and risk of participating the trial and signed on the written consent.

You may not qualify if:

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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (4)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: September 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

KR (4)