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Phosphate Binder

All Patients for Chronic Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by Unicycive Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be willing and able to swallow whole tablets.

Patient must be ≥18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

Study Summary

This trial aims to test if patients with chronic kidney disease on hemodialysis and high levels of phosphorus can tolerate a new drug called oxylanthanum carbonate (OLC). Participants will replace

Who is the study for?

Adults over 18 with chronic kidney disease on hemodialysis and high blood phosphorus levels, who can swallow tablets and follow the study plan. They must have been on dialysis for at least 12 weeks, stable on certain medications, and willing to use contraception. Excluded are those allergic to lanthanum compounds or recently in other drug studies.Check my eligibility

What is being tested?

The trial is testing Oxylanthanum Carbonate (OLC) as a replacement for current phosphate binders in patients undergoing dialysis due to chronic kidney disease with hyperphosphatemia. It aims to determine if OLC is tolerable when taken regularly.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include gastrointestinal issues since OLC is ingested orally and replaces other phosphate binders which often cause such problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow whole tablets.

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I am 18 years old or older.

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I am capable of becoming pregnant and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-related AEs leading to discontinuation

Secondary outcome measures

Adverse Drug Reactions

Area Under the Concentration-Time Curve (AUC) of Lanthanum

Change from Baseline in Clinical Laboratory Tests

+3 more

Other outcome measures

Patient Satisfaction Questionnaire

Trial Design

1Treatment groups

Experimental Treatment

Group I: All PatientsExperimental Treatment1 Intervention

All patients with chronic kidney disease with hyperphosphatemia

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unicycive Therapeutics, IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is this clinical trial being overseen?

"To reduce travel requirements, it is advisable to select a clinic that is located in proximity to your residence. Currently, the study operates from 7 sites including Gallup, San Antonio, and Pine Bluff among other locations."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible candidates. The study was initially posted on December 15th, 2023 and underwent its most recent update on January 11th, 2024. To complete the research successfully, a total of 90 participants will be admitted across seven distinct sites."

Answered by AI

Has the FDA authorized the use of All Patients for medical treatment?

"Given that this trial is classified as Phase 2, indicating limited safety data and no efficacy data supporting All Patients at the moment, our team at Power rates their safety level as a 2 on a scale of 1 to 3."

Answered by AI

Is the enrollment for participants currently open in this medical study?

"Indeed, as per clinicaltrials.gov, this trial is actively soliciting volunteers. The study was first published on December 15th, 2023 and underwent its most recent revision on January 11th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis

2023. "A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218290.

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