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Heart FailurePhase 2NCT01130597

Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

A Phase 2 study testing patiromer and spironolactone in people with Heart Failure, run by Relypsa, Inc. at 13 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
patiromer and spironolactone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
13 sitesin 2 countries
Study dates
May 2010to Sep 2010
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

  • Chronic HF clinically indicated to receive spironolactone therapy
  • Age 18 years or older
  • Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline
  • CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2 at screening based on central lab creatinine measurement)
  • On at least one of the following HF therapies: ACEI, ARB, or BB
  • Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for one month after study completion
  • Male participants and/or their female partners of child-bearing potential must use a highly effective form of contraception during the study and for 3 months after study completion
  • Provide their written informed consent prior to participation in the study

Who cannot join

  • History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
  • Uncorrected primary severe valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
  • Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation
  • Heart transplant recipient, or anticipated need for transplant during study participation
  • Any of the following events having occurred within 2 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
  • Current dialysis participant, or anticipated need for dialysis during study participation
Show all 19Show fewer
  • Prior kidney transplant, or anticipated need for transplant during study participation
  • Metastatic, late-stage or end-stage cancer with < 12 months life expectancy or at risk for tumor lysis syndrome
  • History of alcoholism or drug/chemical abuse within 1 year
  • Sustained systolic blood pressure > 180 or < 90 mmHg
  • Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal
  • Loop and thiazide diuretics that have not been stable for at least 21 days prior to baseline or not anticipated to remain stable during study participation
  • Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation
  • Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation
  • Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline
  • Use of any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to baseline
  • Participants who have taken investigational product in this study, or a previous patiromer study
  • Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
  • In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, serious intercurrent illness, or extenuating circumstance occurring or persisting, within 30 days prior to baseline, that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Georgia8 sites

  • Investigator Site 11

    Tbilisi

  • Investigator Site 12

    Tbilisi

  • Investigator Site 13

    Tbilisi

  • Investigator Site 14

    Tbilisi

  • Investigator Site 15

    Tbilisi

  • Investigator Site 16

    Tbilisi

  • Investigator Site 17

    Tbilisi

  • Investigator Site 18

    Tbilisi

Other trials in Georgia

Slovenia5 sites

  • Investigator Site 25

    Golnik

  • Investigator Site 27

    Izola

  • Investigator Site 21

    Ljubljana

  • Investigator Site 22

    Maribor

  • Investigator Site 26

    Slovenj Gradec

Other trials in Slovenia

About this study

Official title: A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for Patiromer in Heart Failure Patients With Chronic Kidney Disease

The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).

Read the detailed description

This was an open-label, single-arm study to evaluate a titration regimen for patiromer in approximately 63 HF participants with CKD receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study was considered to be exploratory.

Upon successful completion of screening evaluations (-10 to -5 days prior to enrollment), all eligible participants were assigned at Baseline (Day 0 visit) to an initial dose of patiromer (20 g/day) and spironolactone (25 mg/day).

Study visits for enrolled participants were scheduled for Days 3, 7, 14, 21, 28, 35, 42, 49 and 56. A follow-up visit occurred on Day 63.

At selected study visits, patiromer or spironolactone doses may have been titrated. The study dosing algorithm was designed to maintain an individual's serum potassium value in the range of 4.0 - 5.1 mEq/L (based on local lab data).

Any participant with a local laboratory serum potassium value < 3.5 or > 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.

Conditions
Heart Failure
Being tested
patiromer, spironolactone
Keywords
HF, Heart failure, hyperkalemia, chronic kidney disease, prevention of hyperkalemia in heart failure participants
Medical subject headings
Heart Failure, 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 RLY5016, Veltassa

    Active investigational drug

  • spironolactoneDrug

Study groups in NCT01130597
Study groupRoleWhat they receive
patiromerExperimentalspironolactone + patiromer
Receives: Drug: patiromer; Drug: spironolactone

What is being measured

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

  1. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment

    Measured: 56 days

Secondary outcomes (18)

  1. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4

    Measured: 28 Days

  2. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8

    Measured: 56 Days

  3. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4

    Measured: 28 Days

  4. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8

    Measured: 56 Days

  5. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment

    Measured: 56 Days

  6. Mean Dose of Patiromer at End of Treatment

    Measured: 56 Days

  7. Percentage of Participants Requiring Patiromer Uptitration

    Measured: 56 Days

  8. Percentage of Participants Requiring Patiromer Downtitration

    Measured: 56 Days

  9. Median Time to First Patiromer Dose Titration

    Measured: 56 Days

  10. Mean Number of Patiromer Titrations

    Measured: 56 Days

  11. Mean Patiromer Dose at Week 1

    Measured: Up to Week 1

  12. Mean Patiromer Dose at Week 4

    Measured: Up to Week 4

  13. Mean Patiromer Dose at Week 8

    Measured: Up to Week 8

  14. Mean Change From Baseline in Serum Potassium to End of Treatment

    Measured: 56 Days

  15. Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)

    Measured: 56 Days

  16. Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day

    Measured: 56 Days

  17. Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline

    Measured: Baseline and Day 28

  18. Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline

    Measured: Baseline and Day 56

Timeline

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

  1. First posted26 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130597
Sponsor's protocol ID
RLY5016-204
Status last verified
Dec 2015
First submitted
24 May 2010
Last updated
12 May 2021
Data monitoring committee
No

Publications

  • Pitt B, Bushinsky DA, Kitzman DW, Ruschitzka F, Metra M, Filippatos G, Rossignol P, Du Mond C, Garza D, Berman L, Lainscak M; Patiromer-204 Investigators. Evaluation of an individualized dose titration regimen of patiromer to prevent hyperkalaemia in patients with heart failure and chronic kidney disease. ESC Heart Fail. 2018 Jun;5(3):257-266. doi: 10.1002/ehf2.12265. Epub 2018 Jan 25.

    PubMed 29369537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing patiromer and spironolactone in people with Heart Failure, run by Relypsa, Inc. at 13 sites in 2 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 8 inclusion and 19 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 13 sites in Georgia, Slovenia. 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 28 Jan 2016). 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 Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment (time frame: 56 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 NCT01130597, 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.

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