Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
NCT ID: NCT03071263
Last Updated: 2021-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
295 participants
INTERVENTIONAL
2017-01-23
2018-11-27
Brief Summary
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Detailed Description
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All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period).
The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 - Patiromer
spironolactone + blinded patiromer
Patiromer
2 packets/day starting dose, administered orally
Spironolactone
25 mg tablet/day starting dose, administered orally
Group 2 - Placebo
spironolactone + blinded placebo
Placebo
2 packets/day starting dose, administered orally
Spironolactone
25 mg tablet/day starting dose, administered orally
Interventions
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Patiromer
2 packets/day starting dose, administered orally
Placebo
2 packets/day starting dose, administered orally
Spironolactone
25 mg tablet/day starting dose, administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Taking at least three medications for blood pressure (one a diuretic)
* Uncontrolled high blood pressure
* Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2
* Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)
Exclusion Criteria
* Inability to measure BP
* Not taking high blood pressure medications as prescribed medications
* Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis
* Renal transplant
* History of cancer within past 12 months
* Recent cardiovascular event with last 3 months
* Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)
* Inability to take study medication
* Alcoholism
18 Years
ALL
No
Sponsors
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Relypsa, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director or VP Clinical Development
Role: STUDY_DIRECTOR
Relypsa, Inc.
Locations
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Investigator Site 1012
Hollywood, Florida, United States
Investigator Site 1023
Miami Lakes, Florida, United States
Investigator Site 1022
Chicago, Illinois, United States
Investigator Site 1402
Sofia, , Bulgaria
Investiagor Site 2205
Zagreb, , Croatia
Investigator Site 2201
Zagreb, , Croatia
Investigator Site 2202
Zagreb, , Croatia
Investigator Site 2203
Zagreb, , Croatia
Investigator Site 3806
Tbilisi, , Georgia
Investigator Site 3811
Tbilisi, , Georgia
Investigator Site 3802
Tbilisi, , Georgia
Investigator Site 3801
Tbilisi, , Georgia
Investigator Site 3804
Tbilisi, , Georgia
Investigator Site 3805
Tbilisi, , Georgia
Investigator Site 3807
Tbilisi, , Georgia
Investigator Site 3808
Tbilisi, , Georgia
Investigator Site 3810
Tbilisi, , Georgia
Investigator Site 3812
Tbilisi, , Georgia
Investigator Site 3813
Tbilisi, , Georgia
Investigator Site 3809
Tbilisi, , Georgia
Investigator Site 4202
Göttingen, , Germany
Investigator Site 4607
Balatonfüred, , Hungary
Investigator Site 4606
Budapest, , Hungary
Investigator Site 4611
Debrecen, , Hungary
Investigator Site 4601
Hatvan, , Hungary
Investigator Site 4605
Kistarcsa, , Hungary
Investigator Site 4602
Miskolc, , Hungary
Investigator Site 4610
Miskolc, , Hungary
Investigator Site 4608
Mosonmagyaróvár, , Hungary
Investigator Site 7403
Johannesburg, , South Africa
Investiagor Site 7809
Kharkiv, , Ukraine
Investigator Site 7803
Kharkiv, , Ukraine
Investigator Site 7808
Kharkiv, , Ukraine
Investigator Site 7802
Kharkiv, , Ukraine
Investigator Site 7805
Kiev, , Ukraine
Investigator Site 7801
Kiev, , Ukraine
Investigator Site 7804
Zaporizhzhia, , Ukraine
Investigator Site 7807
Zaporizhzhia, , Ukraine
Investigator Site 8202
Leicester, , United Kingdom
Investigator Site 8205
London, , United Kingdom
Countries
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References
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Agarwal R, Rossignol P, Budden J, Mayo MR, Arthur S, Williams B, White WB. Patiromer and Spironolactone in Resistant Hypertension and Advanced CKD: Analysis of the Randomized AMBER Trial. Kidney360. 2021 Jan 15;2(3):425-434. doi: 10.34067/KID.0006782020. eCollection 2021 Mar 25.
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Agarwal R, Rossignol P, Romero A, Garza D, Mayo MR, Warren S, Ma J, White WB, Williams B. Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2019 Oct 26;394(10208):1540-1550. doi: 10.1016/S0140-6736(19)32135-X. Epub 2019 Sep 15.
Agarwal R, Rossignol P, Garza D, Mayo MR, Warren S, Arthur S, Romero A, White WB, Williams B. Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study. Am J Nephrol. 2018;48(3):172-180. doi: 10.1159/000492622. Epub 2018 Sep 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002657-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RLY5016-207
Identifier Type: -
Identifier Source: org_study_id
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