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 (SINGLE)

A Single Center, Open-label, Randomized Pilot Study to Evaluate the Safety and Efficacy of Modified-release Tacrolimus, ADVAGRAF®, Versus Those of Twice-daily Tacrolimus, PROGRAF®, in Stable Renal Recipients (SINGLE)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Renal Transplantation; Stable Renal Recipients
• Intervention / Treatment: Drug: ADVAGRAF; Drug: PROGRAF

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Only patients who meet the following inclusion criteria should be enrolled.

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADVAGRAF group	Drug: ADVAGRAF; oral; Other Names: modified release tacrolimus
Active Comparator: PROGRAF group	Drug: PROGRAF; oral; Other Names: twice-daily tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate (GFR)	Calculated by Modification of Diet in Renal Disease equation	at 24 weeks
Incidence of rejection reactions		at 24 weeks
Blood pressure		at 24 weeks
Survival rate of the grafts		at 24 weeks
Subject's physical condition (SF-35)	Evaluation of subject's physical condition	at 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140524 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: kidney; tacrolimus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: ADV-KT-03