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Clinical Trial Details

Trial ID: L1475
Source ID: NCT03071263
Associated Drug: Patiromer
Title: Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
Acronym: AMBER
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03071263/results
Conditions: Hyperkalemia|Resistant Hypertension
Interventions: DRUG: Patiromer|DRUG: Placebo|DRUG: Spironolactone
Outcome Measures: Primary: Number of Participants Remaining on Spironolactone at Week 12, The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12., At week 12 | Secondary: Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications, AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure, From baseline to Week 12 | Other: Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives, AOBP SBP: Automated Office Systolic Blood Pressure, From baseline to Week 12|Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category, The two baseline potassium subgroups, 4.3-\<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period., From baseline to Week 12|Participants With Central Serum Potassium <5.5 mEq/L Over Time, Baseline Central Serum Potassium: BCSP. The symbols \> and ≤ included in the row titles are used to indicate the time interval \["\>Week1 and ≤Week2" meaning from day 8 until day 14 (included)\]. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period., From baseline to Week 12|Participants Having Spironolactone Titrations Over Time, The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate The symbols \> and ≤ included in the row titles are used to indicate the time interval \["\>Week1 and ≤Week2" meaning from day 8 until day 14 (included)\]., From baseline to Week 12|Number of Participants by Spironolactone Dose Prescribed at Each Visit, QD: Once daily QOD: Once every other day, From baseline to Week 10|Shifts in Selected Laboratory Tests From Baseline to End of Treatment, The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment, From Baseline to End of Treatment, up to 12 weeks.|Spironolactone Dose Level at End of 12 Weeks of Study Treatment, Row title: Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment., 12 Weeks of Study Treatment
Sponsor/Collaborators: Sponsor: Relypsa, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 295
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-01-23
Completion Date: 2018-11-27
Results First Posted: 2020-01-27
Last Update Posted: 2021-05-12
Locations: Investigator Site 1012, Hollywood, Florida, 33021, United States|Investigator Site 1023, Miami Lakes, Florida, 33014, United States|Investigator Site 1022, Chicago, Illinois, 60611, United States|Investigator Site 1402, Sofia, 1612, Bulgaria|Investiagor Site 2205, Zagreb, 10000, Croatia|Investigator Site 2201, Zagreb, 10000, Croatia|Investigator Site 2202, Zagreb, 10000, Croatia|Investigator Site 2203, Zagreb, 10000, Croatia|Investigator Site 3806, Tbilisi, 0102, Georgia|Investigator Site 3811, Tbilisi, 0112, Georgia|Investigator Site 3802, Tbilisi, 0144, Georgia|Investigator Site 3801, Tbilisi, 0159, Georgia|Investigator Site 3804, Tbilisi, 0159, Georgia|Investigator Site 3805, Tbilisi, 0159, Georgia|Investigator Site 3807, Tbilisi, 0159, Georgia|Investigator Site 3808, Tbilisi, 0159, Georgia|Investigator Site 3810, Tbilisi, 0159, Georgia|Investigator Site 3812, Tbilisi, 0159, Georgia|Investigator Site 3813, Tbilisi, 0159, Georgia|Investigator Site 3809, Tbilisi, 0186, Georgia|Investigator Site 4202, Gottingen, 37075, Germany|Investigator Site 4607, Balatonfured, H-8230, Hungary|Investigator Site 4606, Budapest, H-1097, Hungary|Investigator Site 4611, Debrecen, 4032, Hungary|Investigator Site 4601, Hatvan, H-3000, Hungary|Investigator Site 4605, Kistarcsa, H-2143, Hungary|Investigator Site 4602, Miskolc, H-3529, Hungary|Investigator Site 4610, Miskolc, H-3530, Hungary|Investigator Site 4608, Mosonmagyarovar, H-9200, Hungary|Investigator Site 7403, Johannesburg, South Africa|Investigator Site 7803, Khar'kov, 61006, Ukraine|Investiagor Site 7809, Kharkiv, 61002, Ukraine|Investigator Site 7808, Kharkiv, 61039, Ukraine|Investigator Site 7802, Kharkiv, 61103, Ukraine|Investigator Site 7805, Kiev, 03680, Ukraine|Investigator Site 7801, Kiev, 04114, Ukraine|Investigator Site 7804, Zaporizhzhia, 69001, Ukraine|Investigator Site 7807, Zaporizhzhia, 69118, Ukraine|Investigator Site 8202, Leicester, LE5 4QF, United Kingdom|Investigator Site 8205, London, Se5 9RS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03071263