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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier:
NCT01742624
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention Phase
de Novo Kidney Transplantation
 Drug: Advagraf
Drug: Prograf
Drug: Corticosteroid
Drug: Mycophenolate mofetil
 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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure) [ Time Frame: until 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival rate [ Time Frame: at 6 months after treatment ] [ Designated as safety issue: No ]
  • Kidney function (eGFR) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    assessment of eGFR using the Nankivell method

  • 24-hour urine protein and creatinine clearance rate(CCR) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Incidence of new-onset diabetes after kidney transplantation (NODAT) [ Time Frame: until 6 months ] [ Designated as safety issue: Yes ]
  • Safety assessed by the incidence of adverse events, physical exam, and labo-tests [ Time Frame: until 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advagraf group Drug: Advagraf
oral
Other Name: tacrolimus
Drug: Corticosteroid
oral
Drug: Mycophenolate mofetil
oral
Active Comparator: Prograf group Drug: Prograf
oral
Other Name: tacrolimus, FK506
Drug: Corticosteroid
oral
Drug: Mycophenolate mofetil
oral

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742624

Locations
Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Ulsan, 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: NCT01742624     History of Changes
Other Study ID Numbers: ADV-KT-01
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
immunosuppressant
new-onset diabetes after kidney transplantation
NODAT

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013