Chronic Kidney Disease (CKD)Phase 3OPALNCT01810939
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
A Phase 3 study testing Patiromer in people with Chronic Kidney Disease (CKD) and Hyperkalemia (HK), run by Relypsa, Inc. at 58 sites in 10 countries.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease (CKD), Hyperkalemia (HK)
- What is being tested?
- Patiromer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 58 sitesin 10 countries
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ages 18 - 80
- Chronic kidney disease (CKD) - eGFR 15 to < 60 mL/min/1.73m2 at screening
- Hyperkalemia, defined as a serum potassium value of 5.1 to < 6.5 mEq/L at screening
- Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II receptor blocker (ARB), or an aldosterone antagonist (AA) medication
- Informed consent given
Who cannot join
- Participants with auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement
- Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c > 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
- Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
- Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
- Participants with BMI ≥ 40 kg/m2
Trial locations and contacts
58 sites in 10 countries.
58 sites in 10 countries
United States14 sites
Investigator Site 3120
Augusta, Georgia, 30909
Investigator Site 3121
Azusa, California, 91702
Investigator Site 3107
Bethlehem, Pennsylvania, 18017
Investigator Site 3105
Edgewater, Florida, 32132
Investigator Site 3102
Farmington, Missouri, 63640
Investigator Site 3134
Flushing, New York, 11355
Investigator Site 3113
Hollywood, Florida, 33021
Investigator Site 3104
Kansas City, Missouri, 64111
Investigator Site 3133
Los Angeles, California, 90025
Investigator Site 3106
Port Charlotte, Florida, 33952
Investigator Site 3103
Sacramento, California, 95825
Investigator Site 3110
San Antonio, Texas, 78229
Investigator Site 3129
Santa Barbara, California, 93110
Investigator Site 3130
Ventura, California, 93003
Georgia12 sites
Investigator Site 1308
Tbilisi, 0102
Investigator Site 1312
Tbilisi, 0144
Investigator Site 1301
Tbilisi, 0159
Investigator Site 1302
Tbilisi, 0159
Investigator Site 1304
Tbilisi, 0159
Investigator Site 1305
Tbilisi, 0159
Investigator Site 1306
Tbilisi, 0159
Investigator Site 1307
Tbilisi, 0159
Investigator Site 1309
Tbilisi, 0159
Investigator Site 1310
Tbilisi, 0159
Investigator Site 1311
Tbilisi, 0159
Investigator Site 1303
Tbilisi, 0186
Ukraine9 sites
Investigator Site 1915
Ivano-Frankivsk, 76018
Investigator Site 1904
Kharkiv, 61007
Investigator Site 1903
Kharkiv, 61018
Investigator Site 1908
Kharkiv, 61039
Investigator Site 1909
Kyiv, 04114
Investigator Site 1911
Kyiv, 3680
Investigator Site 1914
Luhansk, 91045
Investigator Site 1907
Zaporizhzhya, 69001
Investigator Site 1906
Zaporizhzhya, 69118
Hungary7 sites
Investigator Site 1410
Balatonfüred, H-8230
Investigator Site 1415
Budapest, H-1133
Investigator Site 1401
Győr, H-9024
Investigator Site 1406
Hatvan, H-3000
Investigator Site 1405
Jászberény, H-5100
Investigator Site 1411
Kistarcsa, H-2143
Investigator Site 1407
Veszprém, H-8200
Croatia5 sites
Investigator Site 1103
Karlovac, 47000
Investigator Site 1102
Osijek, 31000
Investigator Site 1104
Zagreb, 10000
Investigator Site 1105
Zagreb, 10000
Investigator Site 1106
Zagreb, 10000
Denmark4 sites
Investigator Site 2103
Aarhus N, 8200
Investigator Site 2107
Fredericia, 7000
Investigator Site 2101
Roskilde, 4000
Investigator Site 2105
Viborg, 8800
Serbia3 sites
Investigator Site 1703
Belgrade, 11000
Investigator Site 1710
Vršac, 26300
Investigator Site 1707
Zrenjanin, 23000
Slovenia2 sites
Investigator Site 1802
Celje, 3000
Investigator Site 1803
Jesenice, 4270
About this study
Official title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
Read the detailed description
There were two parts in the study, Part A and Part B.
Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.
All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).
The dose of patiromer could be titrated based on participant's serum potassium response.
- Conditions
- Chronic Kidney Disease (CKD), Hyperkalemia (HK)
- Being tested
- Patiromer, Placebo
- Keywords
- Chronic Kidney Disease, Treatment of Hyperkalemia, Hyperkalemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatiromerDrug
Also called RLY5016 for Oral Suspension, Veltassa
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Patiromer | Active comparator | Patiromer was administered twice a day as a powder mixed with water. Receives: Drug: Patiromer |
| Placebo | Placebo comparator | Placebo was administered twice a day as a powder mixed with water. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium From Part A Baseline to Part A Week 4
The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).
Measured: Part A Baseline to Part A Week 4
Change in Serum Potassium From Part B Baseline
Change in Serum Potassium from Part B Baseline to either:
Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L.
Measured: Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L
Secondary outcomes (3)
Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4
Measured: Week 4
Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B
Measured: Part B Baseline to Part B Week 8
Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B
Measured: Part B Baseline to Part B Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionAug 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relypsa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director Clinical Operations, Study director, Relypsa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810939
- Sponsor's protocol ID
- RLY5016-301
- Other IDs
- 2012-001956-20
- Acronym
- OPAL
- Status last verified
- May 2021
- First submitted
- 12 Mar 2013
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. doi: 10.1056/NEJMoa1410853. Epub 2014 Nov 21.
PubMed 25415805Natale 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 32588430
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
- ClinicalTrials.gov ID
- NCT01810939
- Acronym / sponsor ID
- OPAL / RLY5016-301
- Conditions
- Chronic Kidney Disease (CKD), Hyperkalemia (HK)
- Keywords
- Chronic Kidney Disease, Treatment of Hyperkalemia, Hyperkalemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Relypsa, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 15 Dec 2015
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 was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
Detailed description
There were two parts in the study, Part A and Part B.
Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.
All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).
The dose of patiromer could be titrated based on participant's serum potassium response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patiromer | Active comparator | Drug: PatiromerPatiromer was administered twice a day as a powder mixed with water. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered twice a day as a powder mixed with water. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ages 18 - 80
- Chronic kidney disease (CKD) - eGFR 15 to < 60 mL/min/1.73m2 at screening
- Hyperkalemia, defined as a serum potassium value of 5.1 to < 6.5 mEq/L at screening
- Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II receptor blocker (ARB), or an aldosterone antagonist (AA) medication
- Informed consent given
Key exclusion criteria (6 listed)
- Participants with auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement
- Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c > 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
- Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
- Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
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: RLY5016 for Oral Suspension, Veltassa | Drug | Patiromer |
| Placebo | Drug | Placebo |
Primary outcome
Change in Serum Potassium From Part A Baseline to Part A Week 4
Time frame: Part A Baseline to Part A Week 4
The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).
Change in Serum Potassium From Part B Baseline
Time frame: Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L
Change in Serum Potassium from Part B Baseline to either: Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L.
3 secondary outcomes
Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4
Time frame: Week 4
Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B
Time frame: Part B Baseline to Part B Week 8
Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B
Time frame: Part B Baseline to Part B Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25415805Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. doi: 10.1056/NEJMoa1410853. Epub 2014 Nov 21.
- 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.
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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.
Director Clinical Operations study director
Relypsa, Inc.
58 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patiromer in people with Chronic Kidney Disease (CKD) and Hyperkalemia (HK), run by Relypsa, Inc. at 58 sites in 10 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 6 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Georgia, Ukraine, Hungary, Croatia and 5 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Dec 2015). 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?
Change in Serum Potassium From Part A Baseline to Part A Week 4 (time frame: Part A Baseline to Part A Week 4). The study lists 2 primary outcomes in all. 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 NCT01810939, which also lists 2 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 3 Jun 2021.