HyperkalemiaPhase 2AMBERNCT03071263
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
A Phase 2 study testing Patiromer and Spironolactone in people with Hyperkalemia and Resistant Hypertension, run by Relypsa, Inc. at 40 sites in 9 countries.
Trial summary
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Resistant Hypertension
- What is being tested?
- Patiromer and Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 40 sitesin 9 countries
- Study dates
- 23 Jan 2017to 27 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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)
Who cannot join
- History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
Georgia12 sites
Investigator Site 3806
Tbilisi, 0102
Investigator Site 3811
Tbilisi, 0112
Investigator Site 3802
Tbilisi, 0144
Investigator Site 3801
Tbilisi, 0159
Investigator Site 3804
Tbilisi, 0159
Investigator Site 3805
Tbilisi, 0159
Investigator Site 3807
Tbilisi, 0159
Investigator Site 3808
Tbilisi, 0159
Investigator Site 3810
Tbilisi, 0159
Investigator Site 3812
Tbilisi, 0159
Investigator Site 3813
Tbilisi, 0159
Investigator Site 3809
Tbilisi, 0186
Hungary8 sites
Investigator Site 4607
Balatonfüred, H-8230
Investigator Site 4606
Budapest, H-1097
Investigator Site 4611
Debrecen, 4032
Investigator Site 4601
Hatvan, H-3000
Investigator Site 4605
Kistarcsa, H-2143
Investigator Site 4602
Miskolc, H-3529
Investigator Site 4610
Miskolc, H-3530
Investigator Site 4608
Mosonmagyaróvár, H-9200
Ukraine8 sites
Investiagor Site 7809
Kharkiv, 61002
Investigator Site 7803
Kharkiv, 61006
Investigator Site 7808
Kharkiv, 61039
Investigator Site 7802
Kharkiv, 61103
Investigator Site 7805
Kiev, 03680
Investigator Site 7801
Kiev, 04114
Investigator Site 7804
Zaporizhzhya, 69001
Investigator Site 7807
Zaporizhzhya, 69118
Croatia4 sites
Investiagor Site 2205
Zagreb, 10000
Investigator Site 2201
Zagreb, 10000
Investigator Site 2202
Zagreb, 10000
Investigator Site 2203
Zagreb, 10000
United States3 sites
Investigator Site 1022
Chicago, Illinois, 60611
Investigator Site 1012
Hollywood, Florida, 33021
Investigator Site 1023
Miami Lakes, Florida, 33014
United Kingdom2 sites
Investigator Site 8202
Leicester, LE5 4QF
Investigator Site 8205
London, Se5 9RS
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
Read the detailed description
Approximately 290 eligible participants with [chronic kidney disease (CKD) on stable doses of medication] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day.
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
- Hyperkalemia, Resistant Hypertension
- Being tested
- Patiromer, Placebo, Spironolactone
- Keywords
- Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease, Hypertension, Resistant Hypertension, Spironolactone
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatiromerDrug
Also called Veltassa, RLY5016 for Oral Suspension, Patiromer for Oral Suspension
2 packets/day starting dose, administered orally
PlaceboDrug
2 packets/day starting dose, administered orally
SpironolactoneDrug
25 mg tablet/day starting dose, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Patiromer | Experimental | spironolactone + blinded patiromer Receives: Drug: Patiromer; Drug: Spironolactone |
| Group 2 - Placebo | Experimental | spironolactone + blinded placebo Receives: Drug: Placebo; Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 12
Secondary outcomes (1)
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
Measured: From baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start23 Jan 2017
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relypsa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director or VP Clinical Development, Study director, Relypsa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071263
- Sponsor's protocol ID
- RLY5016-207
- Other IDs
- 2016-002657-38, 2016
- Acronym
- AMBER
- Status last verified
- May 2021
- First submitted
- 1 Mar 2017
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35369022Natale 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.
PubMed 32588430Agarwal 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.
PubMed 31533906Agarwal 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.
PubMed 30176673
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03071263
- Acronym / sponsor ID
- AMBER / RLY5016-207
- Conditions
- Hyperkalemia, Resistant Hypertension
- Keywords
- Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease, Hypertension, Resistant Hypertension, Spironolactone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Relypsa, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
Detailed description
Approximately 290 eligible participants with [chronic kidney disease (CKD) on stable doses of medication] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Patiromer | Experimental | Drug: Patiromer, Drug: Spironolactonespironolactone + blinded patiromer |
| Group 2 - Placebo | Experimental | Drug: Placebo, Drug: Spironolactonespironolactone + blinded placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- 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)
Key exclusion criteria (10 listed)
- History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatiromerAlso: Veltassa, RLY5016 for Oral Suspension, Patiromer for Oral Suspension2 packets/day starting dose, administered orally | Drug | Group 1 - Patiromer |
| Placebo2 packets/day starting dose, administered orally | Drug | Group 2 - Placebo |
| Spironolactone25 mg tablet/day starting dose, administered orally | Drug | Group 1 - Patiromer, Group 2 - Placebo |
Primary outcome
Number of Participants Remaining on Spironolactone at Week 12
Time frame: 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.
1 secondary outcome
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
Time frame: From baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35369022Agarwal 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.
- Derived from this study: PubMed 32588430Natale 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.
- Derived from this study: PubMed 31533906Agarwal 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.
- Derived from this study: PubMed 30176673Agarwal 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.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director or VP Clinical Development study director
Relypsa, Inc.
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patiromer and Spironolactone in people with Hyperkalemia and Resistant Hypertension, run by Relypsa, Inc. at 40 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Georgia, Hungary, Ukraine, Croatia, United States and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Remaining on Spironolactone at Week 12 (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03071263, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.