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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742676
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Kidney Transplantation Stable Renal Recipients Drug: ADVAGRAF Drug: PROGRAF Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ADVAGRAF group Drug: ADVAGRAF
Other Name: modified release tacrolimus
Active Comparator: PROGRAF group Drug: PROGRAF
Other Name: twice-daily tacrolimus

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: at 24 weeks ]

Secondary Outcome Measures :
  1. Glomerular Filtration Rate (GFR) [ Time Frame: at 24 weeks ]
    Calculated by Modification of Diet in Renal Disease equation

  2. Incidence of rejection reactions [ Time Frame: at 24 weeks ]
  3. Blood pressure [ Time Frame: at 24 weeks ]
  4. Survival rate of the grafts [ Time Frame: at 24 weeks ]
  5. Subject's physical condition (SF-35) [ Time Frame: at 24 weeks ]
    Evaluation of subject's physical condition

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742676

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Korea, Inc. Identifier: NCT01742676     History of Changes
Other Study ID Numbers: ADV-KT-03
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action