A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients

NCT ID: NCT01742676

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.

Conditions

Renal Transplantation; Kidney Transplantation; Stable Renal Recipients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADVAGRAF group

Group Type: EXPERIMENTAL

ADVAGRAF

Intervention Type: DRUG

oral

PROGRAF group

Group Type: ACTIVE_COMPARATOR

PROGRAF

Intervention Type: DRUG

oral

Interventions

ADVAGRAF

oral

Intervention Type: DRUG

PROGRAF

oral

Intervention Type: DRUG

Other Intervention Names

modified release tacrolimus; twice-daily tacrolimus

Eligibility Criteria

Inclusion Criteria

1. Patients who received a kidney at least within 12 months of their study enrollment (from a deceased or living donor)

2. Patients whose tacrolimus dose have not been changed in at least 12 weeks from their study enrollment and whose minimum blood tacrolimus concentration mean value is within 3-10 ng/ml

3. Female patients who showed a negative result in the serum pregnancy test and who agreed to use an effective contraceptive method during the study period

4. Patients who are clinically stable based on the judgment of the investigator

5. Patients who were given enough information regarding the study, understood the objectives and risks of the study, and signed the informed consent form

Exclusion Criteria

Patients who fall under any of the following criteria should not be enrolled in this study.

1. Patients who had received any other organ except a kidney

2. Patients who showed an acute rejection reaction within 12 weeks of their enrollment or who showed an acute rejection reaction that required antilymphocyte antibody therapy within 24 weeks

3. Patients who were diagnosed with a newly developed malignant tumor (Patients with successfully treated squamous cell/basal cell carcinoma can be enrolled, though.)

4. Patients who have a known allergy to the investigational drug (the test/control drug) or to tacrolimus

5. Patients who have an unstable medical condition that may affect the evaluation of the study's objectives based on the investigator's judgment

6. Patients who have any form of drug abuse or mental illness that might complicate communication with the investigators based on the investigator's judgment

7. Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment

8. Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment

9. Patients who are pregnant or breastfeeding

10. Patients who had been HIV-positive

11. Patients who are considered non-compliant with the scheduled study visits in the protocol

12. Patients who have abnormal kidney functions or a serum creatinine level higher than 1.6 mg/dL/GFR (MDRD) or less than 30 mL/min at the screening visit

13. Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment)

14. Patients who have abnormal liver functions: i.e., whose SGPT/ALT and/or SGOT/AST and/or bilirubin is twice higher than the normal range in the center, and who have liver cirrhosis

15. Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ADV-KT-03

Identifier Type: -

Identifier Source: org_study_id