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CompletedNCT02161237OPTIMIZEUpdated Oct 31, 2024

Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation

A Phase 4 interventional study of Advagraf® in Kidney Transplantation, sponsored by Astellas Pharma Inc. Completed at 2 sites in 2 countries. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.

02

Conditions studied

  • Kidney Transplantation

Keywords

  • Acute rejection
  • Advagraf
  • Renal function
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
  • Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
  • Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study

Exclusion criteria

Exclusion Criteria:

  • Receiving or having previously received an organ transplant other than a kidney
  • Cold ischemia time of the donor kidney > 24 hours
  • Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
  • Significant liver disease
  • Receiving a graft from a hepatitis C or B positive donor
  • Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
  • Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
  • Subject or donor known to be HIV positive
  • Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
  • Subject has malignant tumor
  • Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
  • Subject with a high immunological risk
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    standard dose group

    Oral

    Drug: Advagraf®

  • Experimental
    optimized dose group

    Oral

    Drug: Advagraf®

Interventions

  • DrugAdvagraf®

    oral

    Also known as: FK506, tacrolimus

06

What researchers measure

Primary outcomes

  1. estimated GFR

    Time frame: at Week-52 after transplantation

Secondary outcomes

  1. creatinine clearance

    Time frame: at Week-52 after transplantation

  2. serum creatinine level

    Time frame: at Week-52 after transplantation

  3. Number of graft survival

    Time frame: at Week-52 after transplantation

  4. Subject survival

    Time frame: at Week-52 after transplantation

  5. number of biopsy-proven acute rejection

    Time frame: at Week-52 after transplantation

  6. Composite of graft loss, subject death and biopsy proven acute rejection

    Time frame: at Week-52 after transplantation

  7. Time to the first acute rejection

    Time frame: up to Week-52 after transplantation

  8. Time to the first steroid-resistant acute rejection

    Time frame: up to Week-52 after transplantation

  9. Severity of biopsy proven acute rejection

    Severity is evaluated using Banff '07 Criteria

    Time frame: up to Week-52 after transplantation

  10. Safety assessed by the incidence of adverse events, vital signs and lab tests

    Time frame: for 52 weeks after transplantation

07

Study locations

2 sites
  • Seoul, Korea, Republic of
  • Taipei, Taiwan
08

References and documents

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02161237
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Jun 11, 2014
Start date
Jun 26, 2014
Primary completion
Dec 22, 2016
Completion
Dec 22, 2016
Last update
Oct 31, 2024

Study contacts

Medical Director
study director · Astellas Pharma Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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