Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
Condition: Chronic Kidney Disease; Hypertension; Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies; Hypertension; Hyperkalemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study determined the optimal starting dose of patiromer in treating hyperkalemia in
      participants with hypertension and diabetic nephropathy who were already receiving ACEI
      and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and
      safety of patiromer and the long term use of patiromer.
    

Detailed description: 
      RLY5016-205 was an open-label, randomized, dose ranging study to determine the optimal
      starting dose, efficacy and safety of patiromer in treating hyperkalemia in hypertensive
      patients with nephropathy due to type 2 diabetes mellitus (T2DM) who were already receiving
      Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB)
      drugs, with or without spironolactone.

      The study consisted of the following periods:

        -  Screening: Up to 10 days (1 visit)

        -  Run-in for those who were not hyperkalemic at screening (Cohorts 1 and 2): up to 4 weeks
           (1 to 4 visits)

        -  Patiromer Treatment Initiation: first 8 weeks of patiromer treatment (a minimum of 10
           visits)

        -  Patiromer Long-Term Maintenance: additional 44 weeks of patiromer treatment up to a
           total of one year (minimum of 11 additional visits)

        -  Follow-up (after patiromer discontinuation): 1 week (2 visits) OR 4 weeks (5 visits)
           depending on the final serum potassium level
    

Intervention name(s): patiromer; patiromer; patiromer; patiromer; patiromer; patiromer; losartan; spironolactone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cohorts 1, 2 and 3 - Patiromer starting dose: 8.4 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1); Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2); Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1); Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1); Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2); Cohorts 1, 2 and 3 - Patiromer starting dose: 33.6 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2); losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1); Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)
Other intervention name(s): RLY5016 for Oral Suspension; Veltassa; RLY5016 for Oral Suspension; Veltassa; RLY5016 for Oral Suspension; Veltassa; RLY5016 for Oral Suspension; Veltassa; RLY5016 for Oral Suspension; Veltassa; RLY5016 for Oral Suspension; Veltassa
Intervention MeSH terms: Losartan; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperkalemia; Chronic Kidney Disease; Treatment of Hyperkalemia; Hypertension; Diabetic Nephropathy