Clinical trial NCT01371747
Conditions: Chronic Kidney Disease Hypertension Hyperkalemia
Keywords: Hyperkalemia Chronic Kidney Disease Treatment of Hyperkalemia Hypertension Diabetic Nephropathy
Sponsor: Relypsa, Inc.
Start date: 2011-06-01; Completion date: 2013-06-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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

Arms: arm 1: Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L (milliequivalent) arm 2: Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L arm 3: Participants with baseline serum potassium \> 5.0 to 5.5 mEq/L arm 4: Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L arm 5: Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L arm 6: Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L
Interventions: intervention 1: patiromer intervention 2: patiromer intervention 3: patiromer intervention 4: patiromer intervention 5: patiromer intervention 6: patiromer intervention 7: losartan intervention 8: spironolactone
Intervention descriptions: intervention 1: 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) intervention 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 2) intervention 3: 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) intervention 4: 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) intervention 5: 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) intervention 6: 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) intervention 7: losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1) intervention 8: Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)

Protocol documents: