Evaluation of Patiromer in Heart Failure Patients

Heart Failure Clinical Trial

— PEARL-HF  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868439
• Other study ID #: RLY5016-202
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2021
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted. Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Use of aldosterone antagonist in the last 30 days prior to baseline, unless was discontinued due to hyperkalemia
• Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to baseline
• Use of any investigational medication, 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

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia

Intervention

Drug:
• patiromer
Active investigational drug
• placebo
placebo

Locations

Country	Name	City	State
Czechia	Investigator Site 102	Brno
Czechia	Investigator Site 103	Prague
Czechia	Investigator Site 104	Prague
Georgia	Investigator Site 602	Tbilisi
Georgia	Investigator Site 603	Tbilisi
Georgia	Investigator Site 604	Tbilisi
Georgia	Investigator Site 605	Tbilisi
Germany	Investigator Site 201	Gottingen
Germany	Investigator Site 202	Heidelberg
Poland	Investigator Site 305	Warsaw
Russian Federation	Investigator Site 409	Barnaul
Russian Federation	Investigator Site 407	Kemerovo
Russian Federation	Investigator Site 402	Moscow
Russian Federation	Investigator Site 403	Moscow
Russian Federation	Investigator Site 406	Moscow
Russian Federation	Investigator Site 404	St Petersburg
Russian Federation	Investigator Site 405	St Petersburg
Russian Federation	Investigator Site 412	St Petersburg
Ukraine	Investigator Site 507	Dnipropetrovsk
Ukraine	Investigator Site 502	Kharkiv
Ukraine	Investigator Site 509	Kharkiv
Ukraine	Investigator Site 501	Kiev
Ukraine	Investigator Site 504	Kiev
Ukraine	Investigator Site 506	Kiev
United States	Investigator Site 020	Buffalo	New York
United States	Investigator Site 022	Columbus	Ohio
United States	Investigator Site 001	Dallas	Texas
United States	Investigator Site 029	Miami	Florida
United States	Investigator Site 018	Minneapolis	Minnesota
United States	Investigator Site 005	Northport	New York
United States	Investigator Site 009	Peoria	Illinois
United States	Investigator Site 031	Port Charlotte	Florida
United States	Investigator Site 019	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Relypsa, Inc.	Medpace, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Georgia,  Germany,  Poland,  Russian Federation,  Ukraine, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.		Baseline and Day 28
Secondary	Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.	Analysis based on central laboratory data.	28 Days
Secondary	Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).	Analysis based on local laboratory data.	28 Days
Secondary	Proportion of Participants Whose Spironolactone Dose Was Increased.		28 Days
Secondary	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
Secondary	Time to First Elevated Serum K+ > 5.5 mEq/L.		28 Days

External Links

•   Relypsa company website