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

NCT06218290 | Completed Phase 2 FDA Drug

• 1 other identifier: UNI-OLC-201
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug. Participants will continue with their scheduled dialysis treatments and replace their current phosphate binder drug with OLC.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

CKD, ESRD

Outcome Measures

Primary Outcomes (1)

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

  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.

  4 weeks

Secondary Outcomes (6)

• 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

• Time to Peak Plasma Concentration (Tmax) of Lanthanum

  up to 10 weeks

• Elimination Half-Life (t1/2) of Lanthanum

  up to 10 weeks

Other Outcomes (1)

• Patient Satisfaction Questionnaire

  up to 10 weeks

Study Arms (1)

All Patients

EXPERIMENTAL

All patients with chronic kidney disease with hyperphosphatemia

Drug: Oxylanthanum Carbonate

Interventions

Oxylanthanum Carbonate DRUG

Phosphate Binder to Reduce Hyperphosphatemia

Also known as: OLC

All Patients

Eligibility Criteria

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

You may qualify if:

• Patient must be ≥18 years of age.
• Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements.
• Patient must be willing and able to swallow whole tablets.
• Patient has chronic kidney disease and is undergoing, and compliant with, hemodialysis treatment at least 3 times per week for at least 12 weeks prior to signing the ICF, at the Investigator's discretion
• Patient has mean historical serum phosphorous of ≥4.0 mg/dL and ≤7.0 mg/dL while on a phosphate binder (other than lanthanum carbonate) over the 8 weeks prior to signing the ICF
• Patient has study specific Screening laboratory serum phosphorus value ≥4.0 mg/dL and ≤7.5 mg/dL during Screening (this value can be repeated up to two times if the value is outside the range).
• Patient, if on calcimimetic agents or Vitamin D receptor activators (VDRAs), has had no changes in their prescription for at least 4 weeks prior to Day 1 (T1).
• Patient has a single-pool Kt/V of ≥1.2 during the most recent historical monthly laboratory evaluation.
• Patient is willing to practice an effective form of contraception from study entry until at least 14 days after the last dose of OLC.
• Females of childbearing potential must have a negative pregnancy test at Screening.

You may not qualify if:

• Patient with known or suspected intolerance or hypersensitivity to the investigational product or any related lanthanum compound (eg, lanthanum carbonate \[Fosrenol\]).
• Patient has had prior treatment with lanthanum-based phosphate binder (eg, lanthanum carbonate \[Fosrenol\]) within the past 8 weeks prior to signing the ICF.
• Patient's most recent historical PTH \>1500 pg/mL within the last 3 months prior to signing the ICF
• Patient has received any investigational medicinal product (IMP) in a clinical research study within the 30 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer.
• Patient is unable to take drugs orally due to disorders or diseases that may affect gastrointestinal function, such as inflammatory bowel diseases (eg, Crohn's disease, ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy as assessed by the Investigator.
• Patient has a known history of drug or alcohol abuse that the Investigator assesses would interfere with participation in the study.
• Patient has an active uncontrolled infection on Day 1 in the opinion of the Investigator
• Patient has an underlying medical condition or other serious illness that would not be appropriate for this study as assessed by the Investigator.
• Patient is pregnant or breast-feeding.

Sponsors & Collaborators

• Unicycive Therapeutics, Inc: lead

Study Sites (7)

US Renal Care

Pine Bluff, Arkansas, 71603, United States

Location

US Renal Care

Fort Myers, Florida, 33912, United States

Location

US Renal Care

Gallup, New Mexico, 87301, United States

Location

US Renal Care

Cheektowaga, New York, 14215, United States

Location

US Renal Care

Toledo, Ohio, 43613, United States

Location

US Renal Care

San Antonio, Texas, 78211, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

Related Publications (2)

• Block GA, Chertow GM, Reddy G, Hasal SJ, Mourya S, Block M, Gupta S, Pergola PE. A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1259-1267. doi: 10.2215/CJN.0000000780.

  PMID: 40658981 DERIVED

• Mathur V, Walker M, Hasal S, Reddy G, Gupta S. Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate. Clin Ther. 2025 Jan;47(1):70-75. doi: 10.1016/j.clinthera.2024.11.009. Epub 2024 Nov 30.

  PMID: 39617673 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: December 15, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: June 2024

Locations

US (7)