Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

Sponsor
Relypsa, Inc.
Study ID
NCT01371747
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • patiromer — DRUG
    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)
  • patiromer — DRUG
    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)
  • patiromer — DRUG
    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)
  • patiromer — DRUG
    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)
  • patiromer — DRUG
    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)
  • patiromer — DRUG
    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 — DRUG
    losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1)
  • spironolactone — DRUG
    Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)

Study Details

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.

Key Dates

Start date
Jun 30, 2011
Status verified
May 2021
Primary completion
May 31, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
324 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1: 8.4 g/d patiromer
    Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L (milliequivalent)
  • Experimental: Stratum 1: 16.8 g/d patiromer
    Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L
  • Experimental: Stratum 1: 25.2 g/d patiromer
    Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L
  • Experimental: Stratum 2: 16.8 g/d patiromer
    Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L
  • Experimental: Stratum 2: 25.2 g/d patiromer
    Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L
  • Experimental: Stratum 2: 33.6 g/d patiromer
    Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L

Primary Outcome Measure

Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group [ Time Frame: Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation. ]

Related Studies