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Oxylanthanum Carbonate

Phase 2

Chronic Kidney Disease Requiring Chronic Dialysis | Small molecule | Nephrology |Unicycive Therapeutics, Inc.|Last Updated: Jun 24, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

Oxylanthanum Carbonate · 1 trial · 1 indication

Phase 2 1
NCT06218290A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on DialysisChronic Kidney Disease Requiring Chronic Dialysis
COMPLETED106 Analytics
PHASE2COMPLETED
A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
Chronic Kidney Disease Requiring Chronic DialysisUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-related AEs leading to study drug discontinuation during the Maintenance Period.
4 weeks

Tolerability of clinically effective doses of OLC as assessed by the incidence of treatment-related AEs leading to study drug discontinuation during the Maintenance Period.

Secondary Endpoints

Adverse Drug Reactions
up to 10 weeks
Maximum Plasma Concentration (Cmax) of Lanthanum
up to 10 weeks
Area Under the Concentration-Time Curve (AUC) of Lanthanum
up to 10 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
All PatientsEXPERIMENTALAll patients with chronic kidney disease with hyperphosphatemia

Interventions

NameTypeDescription
Oxylanthanum CarbonateDRUGPhosphate Binder to Reduce Hyperphosphatemia
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Patient must be ≥18 years of age. 2. Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements. 3. Patient must be willing and able to swallow whole tablets. 4. Patient has chronic kidney...

Countries:United States
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Frequently asked questions about Oxylanthanum Carbonate

What is Oxylanthanum Carbonate used for?

Oxylanthanum Carbonate is an investigational small molecule being developed for patients with Chronic Kidney Disease Requiring Chronic Dialysis. It is intended for use in the nephrology therapeutic area. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Oxylanthanum Carbonate?

Oxylanthanum Carbonate is being developed by Unicycive Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol UNCY. The company is conducting clinical research to evaluate the drug's tolerability in patients with chronic kidney disease who require dialysis.

What phase is Oxylanthanum Carbonate in?

Oxylanthanum Carbonate is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and tolerability. The drug is being evaluated in patients with Chronic Kidney Disease Requiring Chronic Dialysis.

What clinical trials is Oxylanthanum Carbonate in?

Oxylanthanum Carbonate has one completed clinical trial, identified as NCT06218290, titled "A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis." This Phase 2 study enrolled 106 participants in the United States and was an uncontrolled, open-label trial.

Is Oxylanthanum Carbonate FDA approved?

Oxylanthanum Carbonate is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed trial, NCT06218290, assessed tolerability in 106 patients with chronic kidney disease on dialysis, but the drug has not yet received marketing authorization from regulatory agencies.