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ASTOUND

Trial

Clinical Trial Title

Astagraf XL to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation

Trial Status

Open to Enrollment

Start Date

November 7, 2016

Trial Type

Transplant

Specific Condition

Kidney Transplant

Description

This study will compare the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of "immune activation" (IA) on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.

Specifically, it is designed to compare the effects of twice daily, immediate-release tacrolimus and once daily Astagraf XL on DSA formation and the development of IA in de novo kidney transplant recipients during the first two years following kidney transplantation. Patients will be screened prior to surgery and randomized 1:1 to receive, within 48 hours of transplantation, immediate-release tacrolimus, administered twice daily, or Astagraf XL, as a component of a standard immunosuppression maintenance regimen also consisting of corticosteroids (if given per institutional protocol) and mycophenolate mofetil (MMF) (or Myfortic® equivalent).

Eligibility Criteria

Ages Eligible for Study: 16 Years to 65 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Recipient of a de novo kidney from a living or deceased donor. Note: Recipient of an en bloc deceased donor kidney transplant from a pediatric donor <5 years of age AND weighing greater than 20 kg is allowed.
  • If deceased donor, a Kidney Donor Profile Index (KDPI) ≤ 85 (Extended Criteria Donor (ECD) and Donation after Circulatory Death (DCD) organ recipients are eligible for enrollment).
  • Most recent pre-transplant Calculated Panel Reactivity Antibody (cPRA) ≤ 50%.
  • At least one antigen mismatch.
  • Willingness to comply with study protocol.
  • Subject agrees not to participate in another study while on treatment.
  • Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continuing throughout the study period and for 90 days after the final study drug administration.
  • Male subject must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 90 days after the final study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration

IRB Number

10684

Principal Investigator Name

William Bennett

Contact Name

Sheryl Ames

Phone

503-413-8324

Contact Fax

503-413-6861

Contact E-Mail

sames@lhs.org

Last Updated: Tuesday, November 27, 2018 08:36:12 AM