NCT00868439

Brief Summary

The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
7 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 years until next milestone

Results Posted

Study results publicly available

December 15, 2015

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

March 23, 2009

Results QC Date

November 11, 2015

Last Update Submit

May 10, 2021

Conditions

HyperkalemiaHeart Failure

Keywords

HFHeart failurehyperkalemiachronic kidney diseaseprevention of hyperkalemia in heart failure participants

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.

    Baseline and Day 28

Secondary Outcomes (5)

  • Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.

    28 Days

  • Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).

    28 Days

  • Proportion of Participants Whose Spironolactone Dose Was Increased.

    28 Days

  • Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L

    Baseline and Day 28

  • Time to First Elevated Serum K+ > 5.5 mEq/L.

    28 Days

Study Arms (2)

patiromer

ACTIVE COMPARATOR
Drug: patiromer

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

patiromerDRUG

Active investigational drug

Also known as: RLY5016, Veltassa
patiromer
placeboDRUG

placebo

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR \< 60 mL/min) OR (2) documented history of hyperkalemia within the last 6 months
  • 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
  • Must sign informed consent document

You may not qualify if:

  • History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
  • Uncorrected hemodynamically significant primary 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 3 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
  • Prior kidney transplant, or anticipated need for transplant during study participation
  • Metastatic, late-stage or end-stage cancer with \< 12 months life expectancy
  • History of alcoholism or drug/chemical abuse within 1 year
  • QTcB interval \> 500 msec (Bazett's correction formula)
  • Sustained systolic blood pressure \> 170 or \< 90 mmHg
  • Liver enzymes (ALT, AST) \> 3 times upper limit of normal
  • Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to baseline and are not anticipated to remain stable during study participation
  • Use of any IV cardiac medications within 21 days prior to baseline, or their anticipated need during study participation.
  • Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS, Maalox), or their anticipated need during study participation
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Investigator Site 029

Miami, Florida, 33176, United States

Location

Investigator Site 031

Port Charlotte, Florida, 33952, United States

Location

Investigator Site 009

Peoria, Illinois, 61606, United States

Location

Investigator Site 018

Minneapolis, Minnesota, 55417, United States

Location

Investigator Site 020

Buffalo, New York, 14215, United States

Location

Investigator Site 005

Northport, New York, 11768, United States

Location

Investigator Site 022

Columbus, Ohio, 43210, United States

Location

Investigator Site 001

Dallas, Texas, 75216, United States

Location

Investigator Site 019

Salt Lake City, Utah, 84124, United States

Location

Investigator Site 102

Brno, 62500, Czechia

Location

Investigator Site 104

Prague, 12008, Czechia

Location

Investigator Site 103

Prague, 14021, Czechia

Location

Investigator Site 605

Tbilisi, 0102, Georgia

Location

Investigator Site 602

Tbilisi, 0159, Georgia

Location

Investigator Site 604

Tbilisi, 0164, Georgia

Location

Investigator Site 603

Tbilisi, 0179, Georgia

Location

Investigator Site 201

Göttingen, 37075, Germany

Location

Investigator Site 202

Heidelberg, 69120, Germany

Location

Investigator Site 305

Warsaw, 02637, Poland

Location

Investigator Site 409

Barnaul, 656099, Russia

Location

Investigator Site 407

Kemerovo, 650002, Russia

Location

Investigator Site 406

Moscow, 111020, Russia

Location

Investigator Site 402

Moscow, 111539, Russia

Location

Investigator Site 403

Moscow, 129301, Russia

Location

Investigator Site 404

Saint Petersburg, 197341, Russia

Location

Investigator Site 412

Saint Petersburg, 198205, Russia

Location

Investigator Site 405

Saint Petersburg, 199106, Russia

Location

Investigator Site 507

Dnipropetrovsk, 49023, Ukraine

Location

Investigator Site 502

Kharkiv, 61018, Ukraine

Location

Investigator Site 509

Kharkiv, 61176, Ukraine

Location

Investigator Site 504

Kiev, 03680, Ukraine

Location

Investigator Site 506

Kiev, 03680, Ukraine

Location

Investigator Site 501

Kiev, 04114, Ukraine

Location

Related Publications (2)

  • Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ; PEARL-HF Investigators. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011 Apr;32(7):820-8. doi: 10.1093/eurheartj/ehq502. Epub 2011 Jan 5.

    PMID: 21208974RESULT

  • 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.

    PMID: 32588430DERIVED

MeSH Terms

Conditions

HyperkalemiaHeart FailureRenal Insufficiency, Chronic

Interventions

patiromer

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Information
Organization
Relypsa, Inc.
medinfo@relypsa.com
1-844-relypsa

Study Officials

  • Director Clinical Operations

    Relypsa, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

June 2, 2021

Results First Posted

December 15, 2015

Record last verified: 2021-05

Locations

UA(6)GE(4)RU(8)DE(2)CZ(3)PL(1)US(9)