Clinical trial NCT01742624: Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: de Novo Kidney Transplantation
Keywords: immunosuppressant
new-onset diabetes after kidney transplantation
NODAT
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)
timeFrame: until 6 months
Secondary outcomes:
measure: Survival rate
timeFrame: at 6 months after treatment
measure: Kidney function (eGFR)
timeFrame: at 6 months
measure: 24-hour urine protein and creatinine clearance rate(CCR)
timeFrame: at 6 months
measure: Incidence of new-onset diabetes after kidney transplantation (NODAT)
timeFrame: until 6 months
measure: Safety assessed by the incidence of adverse events, physical exam, and labo-tests
timeFrame: until 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Oh CK, Huh KH, Lee JS, Cho HR, Kim YS. Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation. Yonsei Med J. 2014 Sep;55(5):1341-7. doi: 10.3349/ymj.2014.55.5.1341.