A Study to Compare the Safety and Efficacy of Once-daily ADVAGRAF With Twice-daily PROGRAF in Stable Renal Recipients (SINGLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier:
NCT01742676
First received: December 4, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Renal Transplantation
Kidney Transplantation
Stable Renal Recipients
Drug: ADVAGRAF
Drug: PROGRAF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glomerular Filtration Rate (GFR) [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
    Calculated by Modification of Diet in Renal Disease equation

  • Incidence of rejection reactions [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: at 24 weeks ] [ Designated as safety issue: Yes ]
  • Survival rate of the grafts [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
  • Subject's physical condition (SF-35) [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
    Evaluation of subject's physical condition


Enrollment: 100
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADVAGRAF group Drug: ADVAGRAF
oral
Other Name: modified release tacrolimus
Active Comparator: PROGRAF group Drug: PROGRAF
oral
Other Name: twice-daily tacrolimus

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742676

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

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier: NCT01742676     History of Changes
Other Study ID Numbers: ADV-KT-03
Study First Received: December 4, 2012
Last Updated: July 8, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
tacrolimus
kidney

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014