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Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation (AdProCISE)

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: NCT01742624
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : October 10, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Brief Summary:
To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.

Condition or disease Intervention/treatment Phase
de Novo Kidney Transplantation Drug: Advagraf Drug: Prograf Drug: Corticosteroid Drug: Mycophenolate mofetil Phase 4

Detailed Description:
This study is a multicenter, open-label, randomized, parallel, and comparative clinical trial. All the enrolled subjects will be treated with Prograf® (Tacrolimus), Basilixumab, Corticosteroids, and Mycophenolate Mofetil to suppress their immune system for one month (30 days) after their kidney transplant. After the one month, the experimental group (30 subjects) will be treated with Advagraf® (Extended Release Tacrolimus) instead of Prograf® (Tacrolimus), and the Corticosteroids and Mycophenolate Mofetil will be maintained. The control group (30 subjects) will continuously receive Prograf® (Tacrolimus), Corticosteroids, and Mycophenolate Mofetil. The clinical progress of the subjects in the experimental and control groups up to six months after their transplant will be investigated and compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Parallel Clinical Investigation of the Safety and Efficacy of Advagraf® (Extended Release Tacrolimus) vs. Prograf® (Tacrolimus) in de Novo Kidney Recipients 1 Month After Kidney Transplantation
Study Start Date : April 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Advagraf group Drug: Advagraf
Other Name: tacrolimus

Drug: Corticosteroid

Drug: Mycophenolate mofetil

Active Comparator: Prograf group Drug: Prograf
Other Name: tacrolimus, FK506

Drug: Corticosteroid

Drug: Mycophenolate mofetil

Primary Outcome Measures :
  1. Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure) [ Time Frame: until 6 months ]

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: at 6 months after treatment ]
  2. Kidney function (eGFR) [ Time Frame: at 6 months ]
    assessment of eGFR using the Nankivell method

  3. 24-hour urine protein and creatinine clearance rate(CCR) [ Time Frame: at 6 months ]
  4. Incidence of new-onset diabetes after kidney transplantation (NODAT) [ Time Frame: until 6 months ]
  5. Safety assessed by the incidence of adverse events, physical exam, and labo-tests [ Time Frame: until 6 months ]

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.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who are planning to receive a kidney from a deceased/cadaveric donor or a living non-related/related donor
  • Patients who are planning to undergo kidney transplantation through a 15- 65-year-old donor
  • Patients who are willing and able to participate in this study, who signed the informed consent form after following the appropriate informed consent process, and who can visit the center based on the study schedule in the protocol.

Exclusion Criteria:

  • Patients who had received a kidney or another organ and who will receive other organs with the kidney or two kidneys
  • Patients who will receive a kidney from a cadaveric donor whose heart is no longer beating or from an organ donor after cardiac death [Patients, however, who will receive a kidney from a marginal donor (based on KONOS) can be enrolled based on the principal investigator's judgment.]
  • Patients who will receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient or who had positive lymphocyte cross-match (LCM) results
  • Patients who will receive a kidney from a related donor who showed HLA-0 mismatch (identical) (If the donor is not related to the patient or is deceased, however, the patient can be enrolled in this study even if the patient showed HLA-0 mismatch or HLA-6 antigen match.)
  • Patients who previously underwent or are planning to undergo transplantation of their extra-renal solid organ or bone marrow/stem cell
  • Patients who were diagnosed with cancer in the last five years [ Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) can be enrolled.]
  • Patients or donors who have positive HIV, HBsAg, or anti-HCV test results
  • Patients who have a history of hypersensitivity or allergy [that required acute (within four weeks)/chronic treatment] to the investigated drug or another drug with a similar chemical structure (e.g., Tacrolimus).
  • Patients who were treated with other investigated drugs within 30 days from their study enrollment
  • Patients who are planning to be pregnant, or who are pregnant or breastfeeding and who are not planning to use any contraceptive method during the study period.
  • Patients who were addicted to drugs/alcohol within six months of their study enrollment or who have a mental illness that makes appropriate communication with them impossible
  • Patients who showed the following result in the assessment prior to the kidney transplantation

    • Any of their liver panels (AST, ALT, ALKP, and total bilirubin) three times higher than the normal range
    • Absolute neutrophil count < 1,500/mm3, leukocytes < 2,500/mm3, or platelet < 100,000/mm3

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): NCT01742624

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Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Korea, Inc. Identifier: NCT01742624    
Other Study ID Numbers: ADV-KT-01
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
new-onset diabetes after kidney transplantation
Additional relevant MeSH terms:
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Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents