NCT01371747 - Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN) | Biotech Hunter

Enrollment

324

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

June 30, 2013

Conditions

Chronic Kidney DiseaseHypertensionHyperkalemia

Interventions

DRUG

patiromer

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)

DRUG

patiromer

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)

DRUG

patiromer

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)

DRUG

patiromer

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)

DRUG

patiromer

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)

DRUG

patiromer

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)

DRUG

losartan

losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1)

DRUG

spironolactone

Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)

Trial Locations (43)

1097

Investigator Site 508, Budapest

1106

Investigator Site 502, Budapest

2000

Investigator Site 701, Maribor

2380

Investigator Site 704, Slovenj Gradec

3000

Investigator Site 523, Hatvan

Investigator Site 703, Celje

3800

Investigator Site 505, Szikszó

4204

Investigator Site 706, Golnik

4270

Investigator Site 708, Jesenice

4600

Investigator Site 503, Kisvárda

5290

Investigator Site 707, Šempeter pri Gorici

10000

Investigator Site 202, Zagreb

Investigator Site 204, Zagreb

Investigator Site 208, Zagreb

11000

Investigator Site 601, Belgrade

Investigator Site 602, Belgrade

Investigator Site 604, Belgrade

Investigator Site 605, Belgrade

21000

Investigator Site 603, Novi Sad

23000

Investigator Site 607, Zrenjanin

31000

Investigator Site 207, Osijek

47000

Investigator Site 201, Karlovac

51000

Investigator Site 203, Rijeka

0102

Investigator Site 305, Tbilisi

0144

Investigator Site 309, Tbilisi

0159

Investigator site 301, Tbilisi

Investigator Site 302, Tbilisi

Investigator Site 303, Tbilisi

Investigator Site 304, Tbilisi

Investigator Site 306, Tbilisi

Investigator Site 307, Tbilisi

Investigator Site 310, Tbilisi

Investigator Site 311, Tbilisi

0186

Investigator Site 308, Tbilisi

H-1041

Investigator Site 514, Budapest

H-1097

Investigator Site 513, Budapest

H-1115

Investigator Site 517, Budapest

H-9024

Investigator Site 522, Győr

H-5100

Investigator Site 515, Jászberény

H-2143

Investigator Site 506, Kistarcsa

H-9200

Investigator Site 510, Mosonmagyaróvár

H-8000

Investigator Site 504, Székesfehérvár

H-8200

Investigator Site 507, Veszprém

All Listed Sponsors

lead

Relypsa, Inc.

INDUSTRY