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

NCT01130597 | Completed Phase 2 Results

• 1 other identifier: RLY5016-204
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 13

Brief 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).

Conditions

Heart Failure

Keywords

HF; Heart failure; hyperkalemia; chronic kidney disease; prevention of hyperkalemia in heart failure participants

Outcome Measures

Primary Outcomes (1)

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

  56 days

Secondary Outcomes (18)

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

  28 Days

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

  56 Days

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

  28 Days

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

  56 Days

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

  56 Days

Study Arms (1)

patiromer

EXPERIMENTAL

spironolactone + patiromer

Drug: patiromer; Drug: spironolactone

Interventions

patiromer DRUG

Active investigational drug

Also known as: RLY5016, Veltassa

patiromer

spironolactone DRUG

patiromer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Relypsa, Inc.: lead

Study Sites (13)

Investigator Site 11

Tbilisi, Georgia

Location

Investigator Site 12

Tbilisi, Georgia

Location

Investigator Site 13

Tbilisi, Georgia

Location

Investigator Site 14

Tbilisi, Georgia

Location

Investigator Site 15

Tbilisi, Georgia

Location

Investigator Site 16

Tbilisi, Georgia

Location

Investigator Site 17

Tbilisi, Georgia

Location

Investigator Site 18

Tbilisi, Georgia

Location

Investigator Site 25

Golnik, Slovenia

Location

Investigator Site 27

Izola, Slovenia

Location

Investigator Site 21

Ljubljana, Slovenia

Location

Investigator Site 22

Maribor, Slovenia

Location

Investigator Site 26

Slovenj Gradec, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 29369537 DERIVED

MeSH Terms

Conditions

Heart Failure; Hyperkalemia; Renal Insufficiency, Chronic

Interventions

patiromer; Spironolactone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 26, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 12, 2021
• Results First Posted: January 28, 2016

Record last verified: 2015-12

Locations

GE (8); SL (5)