HyperkalemiaPhase 4TOURMALINENCT02694744

Patiromer With or Without Food for the Treatment of Hyperkalemia

A Phase 4 study testing patiromer in people with Hyperkalemia, run by Relypsa, Inc. at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperkalemia
What is being tested?: patiromer
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 29 sitesUnited States
Study dates: Feb 2016to Aug 2016
Phase: Phase 4
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

Potassium concentration > 5.0 mEq/L from two blood draws at Screening
Stable RAASi medication, if taking
Medications taken on a chronic basis are given once daily or twice daily
Informed consent given

Who cannot join

Expected need for dialysis
Major organ transplant
History of conditions associated with pseudohyperkalemia
History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Cancer or unstable medical condition

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Investigator Site 39
Aurora, Illinois, 60504
Investigator Site 33
Dallas, Texas, 75231
Investigator Site 24
Denver, Colorado, 80230
Investigator Site 30
Edgewater, Florida, 32132
Investigator Site 23
Flint, Michigan, 48504
Investigator Site 37
Flushing, New York, 11355
Investigator Site 12
Fountain Valley, California, 92708
Investigator Site 10
Hialeah, Florida, 33012
Investigator Site 13
Hollywood, Florida, 33021
Investigator Site 11
Huntington Beach, California, 92648
Investigator Site 40
Jackson, Tennessee, 38305
Investigator Site 34
Kansas City, Missouri, 64111
Investigator Site 41
Las Vegas, Nevada, 89106
Investigator Site 17
Lauderdale Lakes, Florida, 33313-1638
Investigator Site 16
Lauderdale Lakes, Florida, 33319
Investigator Site 44
Meridian, Idaho, 83642
Investigator Site 15
Miami, Florida, 33015
Investigator Site 43
Miami, Florida, 33147
Investigator Site 36
Norman, Oklahoma, 73069
Investigator Site 38
Palm Springs, California, 92262
Investigator Site 18
Pembroke Pines, Florida, 33028
Investigator Site 20
Riverside, California, 92505
Investigator Site 22
Salt Lake City, Utah, 84124
Investigator Site 26
San Antonio, Texas, 78202
Investigator Site 29
San Antonio, Texas, 78207
Investigator Site 28
San Antonio, Texas, 78215
Investigator Site 25
San Antonio, Texas, 78229
Investigator Site 21
San Dimas, California, 91773
Investigator Site 27
Tampa, Florida, 33614

Other trials in United States

About this study

Official title: The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Read the detailed description

Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Conditions: Hyperkalemia
Being tested: patiromer
Keywords: Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease
Medical subject headings: Hyperkalemia, Renal Insufficiency, Chronic

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
8.4 g/day starting dose, administered orally

Study groups in NCT02694744
Study group	Role	What they receive
Group 1 - Dosing Without Food	Experimental	Patiromer dosing without food Receives: Drug: patiromer
Group 2 - Dosing With Food	Active comparator	Patiromer dosing with food Receives: Drug: patiromer

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
Measured: 21 to 28 Days

Secondary outcomes (1)

Mean Change in Serum Potassium From Baseline to Week 4
An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.
Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Aug 2016

First posted29 Feb 2016 (estimated)
Study startFeb 2016
Primary completionJul 2016
Study completionAug 2016

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 (1)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02694744
Sponsor's protocol ID: RLY5016-401
Acronym: TOURMALINE
Status last verified: May 2021
First submitted: 25 Feb 2016
Last updated: 12 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32588430

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Hyperkalemia trials

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: The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)
ClinicalTrials.gov ID: NCT02694744
Acronym / sponsor ID: TOURMALINE / RLY5016-401
Conditions: Hyperkalemia
Keywords: Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Relypsa, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Jul 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 29 Feb 2016 (estimated)
Results: Posted 20 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 - Dosing Without Food	Experimental	Drug: patiromerPatiromer dosing without food
Group 2 - Dosing With Food	Active comparator	Drug: patiromerPatiromer dosing with food

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Potassium concentration > 5.0 mEq/L from two blood draws at Screening
Stable RAASi medication, if taking
Medications taken on a chronic basis are given once daily or twice daily
Informed consent given

Key exclusion criteria (5 listed)

Expected need for dialysis
Major organ transplant
History of conditions associated with pseudohyperkalemia
History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Cancer or unstable medical condition

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 Suspension8.4 g/day starting dose, administered orally	Drug	Group 1 - Dosing Without Food, Group 2 - Dosing With Food

Primary outcome

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
Time frame: 21 to 28 Days

1 secondary outcome

Mean Change in Serum Potassium From Baseline to Week 4
Time frame: Baseline to Day 28

Results and safety

Results posted to the registry on 20 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - Dosing Without Food	57	51
Group 2 - Dosing With Food	57	52

Primary outcome: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4

Time frame: 21 to 28 Days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1 - Dosing Without Food n = 57	Group 2 - Dosing With Food n = 55
Value	82.5 (70.1 to 91.3)	87.3 (75.5 to 94.7)

Population analysed: The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - Dosing Without Food	4 of 57 (7%)	4 of 57 (7%)	1 of 57
Group 2 - Dosing With Food	1 of 56 (1.8%)	8 of 56 (14.3%)	0 of 56

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 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.
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.

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing patiromer in people with Hyperkalemia, run by Relypsa, Inc. at 29 sites in United States.

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 4 inclusion and 5 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 29 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Nov 2017). 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?

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 (time frame: 21 to 28 Days). 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 NCT02694744, which also lists 1 linked publication.

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.