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

NCT01742624 | Completed Phase 4

• 1 other identifier: ADV-KT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

de Novo Kidney Transplantation

Keywords

immunosuppressant; new-onset diabetes after kidney transplantation; NODAT

Outcome Measures

Primary Outcomes (1)

• Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)

  until 6 months

Secondary Outcomes (5)

• Survival rate

  at 6 months after treatment

• Kidney function (eGFR)

  at 6 months

• 24-hour urine protein and creatinine clearance rate(CCR)

  at 6 months

• Incidence of new-onset diabetes after kidney transplantation (NODAT)

  until 6 months

• Safety assessed by the incidence of adverse events, physical exam, and labo-tests

  until 6 months

Study Arms (2)

Advagraf group

EXPERIMENTAL

Drug: Advagraf; Drug: Corticosteroid; Drug: Mycophenolate mofetil

Prograf group

ACTIVE COMPARATOR

Drug: Prograf; Drug: Corticosteroid; Drug: Mycophenolate mofetil

Interventions

Advagraf DRUG

oral

Also known as: tacrolimus

Advagraf group

Prograf DRUG

oral

Also known as: tacrolimus, FK506

Prograf group

Corticosteroid DRUG

oral

Advagraf group; Prograf group

Mycophenolate mofetil DRUG

oral

Advagraf group; Prograf group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (3)

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25048494 DERIVED

MeSH Terms

Interventions

Tacrolimus; Adrenal Cortex Hormones; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 5, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

KR (3)