Clinical Trial Details
| Trial ID: | L0786 |
| Source ID: | NCT01371747 |
| Associated Drug: | Patiromer |
| Title: | Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN) |
| Acronym: | AMETHYST-DN |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01371747/results |
| Conditions: | Chronic Kidney Disease|Hypertension|Hyperkalemia |
| Interventions: | DRUG: patiromer|DRUG: patiromer|DRUG: patiromer|DRUG: patiromer|DRUG: patiromer|DRUG: patiromer|DRUG: losartan|DRUG: spironolactone |
| Outcome Measures: | Primary: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group, Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates., Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation. | Secondary: Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group, Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates., Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group, Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates., Baseline to Day 3|Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group, Baseline to Week 52|Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days, Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days|Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group, Baseline to Week 8|Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group, Baseline to Week 8|Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group, Baseline to Week 8|Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group, Baseline to Week 52 |
| Sponsor/Collaborators: | Sponsor: Relypsa, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 324 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2011-06 |
| Completion Date: | 2013-06 |
| Results First Posted: | 2015-12-17 |
| Last Update Posted: | 2021-06-03 |
| Locations: | Investigator Site 201, Karlovac, 47000, Croatia|Investigator Site 207, Osijek, 31000, Croatia|Investigator Site 203, Rijeka, 51000, Croatia|Investigator Site 202, Zagreb, 10000, Croatia|Investigator Site 204, Zagreb, 10000, Croatia|Investigator Site 208, Zagreb, 10000, Croatia|Investigator Site 305, Tbilisi, 0102, Georgia|Investigator Site 309, Tbilisi, 0144, Georgia|Investigator site 301, Tbilisi, 0159, Georgia|Investigator Site 302, Tbilisi, 0159, Georgia|Investigator Site 303, Tbilisi, 0159, Georgia|Investigator Site 304, Tbilisi, 0159, Georgia|Investigator Site 306, Tbilisi, 0159, Georgia|Investigator Site 307, Tbilisi, 0159, Georgia|Investigator Site 310, Tbilisi, 0159, Georgia|Investigator Site 311, Tbilisi, 0159, Georgia|Investigator Site 308, Tbilisi, 0186, Georgia|Investigator Site 508, Budapest, 1097, Hungary|Investigator Site 502, Budapest, 1106, Hungary|Investigator Site 514, Budapest, H-1041, Hungary|Investigator Site 513, Budapest, H-1097, Hungary|Investigator Site 517, Budapest, H-1115, Hungary|Investigator Site 522, Gyor, H-9024, Hungary|Investigator Site 523, Hatvan, 3000, Hungary|Investigator Site 515, Jaszbereny, H-5100, Hungary|Investigator Site 506, Kistarcsa, H-2143, Hungary|Investigator Site 503, Kisvarda, 4600, Hungary|Investigator Site 510, Mosonmagyarovar, H-9200, Hungary|Investigator Site 504, Szekesfehervar, H-8000, Hungary|Investigator Site 505, Szikszo, 3800, Hungary|Investigator Site 507, Veszprem, H-8200, Hungary|Investigator Site 601, Belgrade, 11000, Serbia|Investigator Site 602, Belgrade, 11000, Serbia|Investigator Site 604, Belgrade, 11000, Serbia|Investigator Site 605, Belgrade, 11000, Serbia|Investigator Site 603, Novi Sad, 21000, Serbia|Investigator Site 607, Zrenjanin, 23000, Serbia|Investigator Site 703, Celje, 3000, Slovenia|Investigator Site 706, Golnik, 4204, Slovenia|Investigator Site 708, Jesenice, 4270, Slovenia|Investigator Site 701, Maribor, 2000, Slovenia|Investigator Site 704, Slovenj Gradec, 2380, Slovenia|Investigator Site 707, Šempeter pri Gorici, 5290, Slovenia |
| URL: | https://clinicaltrials.gov/show/NCT01371747 |
