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COMPLETED Phase 3

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

NCT01810939 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

Interventions

  • DRUG Placebo
  • DRUG Patiromer

Study Locations (20)

Other

  • Investigator Site 1103 — Karlovac
  • Investigator Site 1102 — Osijek
  • Investigator Site 1104 — Zagreb
  • Investigator Site 1105 — Zagreb
  • Investigator Site 1106 — Zagreb
  • Investigator Site 1205 — Znojmo

California

  • Investigator Site 3121 — Azusa
  • Investigator Site 3133 — Los Angeles
  • Investigator Site 3103 — Sacramento
  • Investigator Site 3129 — Santa Barbara
  • Investigator Site 3130 — Ventura

Florida

  • Investigator Site 3105 — Edgewater
  • Investigator Site 3113 — Hollywood
  • Investigator Site 3106 — Port Charlotte

Missouri

  • Investigator Site 3102 — Farmington
  • Investigator Site 3104 — Kansas City

Georgia

  • Investigator Site 3120 — Augusta

New York

  • Investigator Site 3134 — Flushing

Pennsylvania

  • Investigator Site 3107 — Bethlehem

Texas

  • Investigator Site 3110 — San Antonio

Trial Details

FieldValue
Enrollment Target 243 participants
Start Date 2013-02
Est. Completion 2013-08
Phase Phase 3

Sponsor

Relypsa

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01810939

The ClinicalTrials.gov registry entry for NCT01810939 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Relypsa, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Chronic Kidney Disease (CKD) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01810939 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01810939 about?

NCT01810939 is a clinical study titled "A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)". The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the re...

What is the current status of trial NCT01810939?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2013-02. Estimated completion is 2013-08.

What conditions does trial NCT01810939 study?

This clinical trial studies the following conditions: Chronic Kidney Disease (CKD), Hyperkalemia (HK). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01810939?

The interventions under investigation include: Placebo (DRUG), Patiromer (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01810939?

This trial is sponsored by Relypsa, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01810939 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial