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A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone

Trial Profile

A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Patiromer (Primary) ; Losartan; Spironolactone
  • Indications Hyperkalaemia
  • Focus Therapeutic Use
  • Acronyms AMETHYST-DN
  • Sponsors Relypsa
  • Most Recent Events

    • 01 Jul 2023 Results of post hoc pooled analysis (n=578) assessing the effect of patiromer on sP in patients with CKD, hyperkalemia, and hyperphosphatemia published in the American Journal of Kidney Diseases
    • 11 Jun 2019 Results assessing the effect of Patiromer in in a subgroup of patients 75 Years or Older with Diabetic Kidney Disease and Hyperkalemia Receiving a RAAS Inhibitor, presented at the 79th Annual Scientific Sessions of the American Diabetes Association
    • 11 Apr 2018 According to the Relypsa media release, findings from pooled analysis from this and other two trials (OPAL-HK and TOURMALINE) will be presented in a poster session at the National Kidney Foundation's (NKF) 2018 Spring Clinical Meetings (SCM18).
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