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

Kidney Transplantation Clinical Trial

— PeACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839929
• Other study ID #: ADV-KT-02
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2013
• Last updated: April 30, 2013
• Start date: September 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Prograf
oral
• Advagraf
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glomerular filtration rate (GFR) at Week 24 from baseline		Baseline and Week-24	No
Secondary	Change in Blood Pressure (BP) at Week 24 from baseline		Baseline and Week-24	No
Secondary	Change in HbA1c at Week 24 from baseline		Baseline and Week-24	No
Secondary	Change in tacrolimus blood trough level at Week 24 from baseline		Baseline and Week-24	No
Secondary	Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests		For 24 weeks	No
Secondary	Overall frequency of acute rejection		For 24 weeks	No