Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

NCT02933450 | Completed Phase 4 Results

• 1 other identifier: H-39340
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Efficacy of Patiromer in Reducing Serum Potassium

  serial serum potassium levels will be graphed and compared between the 2 groups

  6 hours

Secondary Outcomes (1)

• Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.

  6 hours

Study Arms (2)

Patiromer group

ACTIVE COMPARATOR

Patiromer 25.2 g dose

Drug: Patiromer 25.2 g

Standard of Care group

NO INTERVENTION

Standard of Care

Interventions

Patiromer 25.2 g DRUG

Single dose of Patiromer 25.2 g

Patiromer group

Eligibility Criteria

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

You may qualify if:

• ESRD patients with serum potassium greater than or equal to 6.0 mEq/L
• Emergent dialysis not expected to be available for 6 hours

You may not qualify if:

• new clinically significant arrhythmia on initial ECG
• patiromer is contraindicated
• have received SPS

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Relypsa, Inc.: collaborator

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

patiromer

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Results Point of Contact

• Title: Dr Zubaid Rafiue
• Organization: Emergency Department, Baylor College of Medicine

zubaidrafique@gmail.com

7138732626

Study Officials

• Zubaid Rafique, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: October 14, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 9, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)