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A Comparison of Effects of Standard Dose vs. Low Dose Advagraf With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response

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Trial Profile

A Comparison of Effects of Standard Dose vs. Low Dose Advagraf With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Tacrolimus (Primary) ; Basiliximab; Corticosteroids; Corticosteroids; Irbesartan; Methylprednisolone; Mycophenolate mofetil; Prednisone; Ramipril
  • Indications Renal transplant rejection
  • Focus Adverse reactions; Registrational
  • Sponsors Astellas Pharma

Most Recent Events

  • 23 Dec 2018 Primary endpoint has not been met. (The prevalence of IF/TA (defined as ci+ct2) at Month 24 (in the ACEi/ARB vs OAHT intervention groups).), as reported in ab article published in the American Journal of Transplantation.
  • 23 Dec 2018 Primary endpoint has not been met. (The incidence of allograft interstitial fibrosis and tubular atrophy (IF/TA) as assessed at a central pathology lab), as reported in ab article published in the American Journal of Transplantation.
  • 23 Dec 2018 Results published in the American Journal of Transplantation

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