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

A Multicenter, Multidose, Study to Assess the Tolerability and Pharmacokinetics of Oxylanthanum Carbonate at Clinically Effective Doses in Patients With Chronic Kidney Disease on Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Drug: Oxylanthanum Carbonate

Detailed Description

This is a 17-week study consisting of 4 parts. In Part 1, patients are screened for eligibility. In Part 2 patients undergo approximately 3-weeks of washout from previous phosphate binder therapy. Part 3 of the study is up to 6-week titration period where patients are treated with OLC starting at a dose level of 1500 mg/day. At the end of 2 weeks, the dose will be adjusted based on serum phosphate level, up to a maximum dose of 3000 mg/day. Part 4 of the study is a 4-week Maintenance Period with patients treated for 4 weeks on the clinically effective dose of oxylanthanum carbonate (OLC) identified in the Titration Period. Patients will return to the clinic for the End-of-Study Visit on the last day of the 4-week Maintenance Period before restarting their prescribed phosphate binder therapy. The primary endpoint will be to evaluate the tolerability of OLC (as assessed by rate of discontinuations due to treatment-related adverse events) and the secondary endpoints are the evaluation of the safety of clinically effective doses of OLC and evaluate the pharmacokinetics of OLC. Once weekly, at one of the patient's scheduled dialysis appointments and at the End-of-Study Visit, the tolerability will be assessed. After the End-of-Study Visit, patients will reinitiate standard therapy. Toxicity will be assessed during the study based on the severity grade (mild, moderate, or severe) as assessed by the Investigator.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Pine Bluff, Arkansas, United States, 71603
      • US Renal Care
  • Florida
    • Fort Myers, Florida, United States, 33912
      • US Renal Care
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • US Renal Care
  • New York
    • Cheektowaga, New York, United States, 14215
      • US Renal Care
  • Ohio
    • Toledo, Ohio, United States, 43613
      • US Renal Care
  • Texas
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
    • San Antonio, Texas, United States, 78211
      • US Renal Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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
5. 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
6. 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).
7. 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).
8. Patient has a single-pool Kt/V of ≥1.2 during the most recent historical monthly laboratory evaluation.
9. Patient is willing to practice an effective form of contraception from study entry until at least 14 days after the last dose of OLC.
10. Females of childbearing potential must have a negative pregnancy test at Screening.

Exclusion Criteria:

1. Patient with known or suspected intolerance or hypersensitivity to the investigational product or any related lanthanum compound (eg, lanthanum carbonate [Fosrenol]).
2. Patient has had prior treatment with lanthanum-based phosphate binder (eg, lanthanum carbonate [Fosrenol]) within the past 8 weeks prior to signing the ICF.
3. Patient's most recent historical PTH >1500 pg/mL within the last 3 months prior to signing the ICF
4. 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.
5. 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.
6. Patient has a known history of drug or alcohol abuse that the Investigator assesses would interfere with participation in the study.
7. Patient has an active uncontrolled infection on Day 1 in the opinion of the Investigator
8. Patient has an underlying medical condition or other serious illness that would not be appropriate for this study as assessed by the Investigator.
9. Patient is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Patients; All patients with chronic kidney disease with hyperphosphatemia	Drug: Oxylanthanum Carbonate; Phosphate Binder to Reduce Hyperphosphatemia; Other Names: OLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Reactions	To evaluate the safety of clinically effective doses of OLC	up to 10 weeks
Maximum Plasma Concentration (Cmax) of Lanthanum	To evaluate the pharmacokinetics (PK) of OLC	up to 10 weeks
Area Under the Concentration-Time Curve (AUC) of Lanthanum	To evaluate the pharmacokinetics (PK) of OLC	up to 10 weeks
Time to Peak Plasma Concentration (Tmax) of Lanthanum	To evaluate the pharmacokinetics (PK) of OLC	up to 10 weeks
Elimination Half-Life (t1/2) of Lanthanum	To evaluate the pharmacokinetics (PK) of OLC	up to 10 weeks
Change from Baseline in Clinical Laboratory Tests	Hematology and Biochemistry	Up to 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire	Assessment of patient satisfaction with OLC treatment	up to 10 weeks

Collaborators and Investigators

• Sponsor: Unicycive Therapeutics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: CKD, ESRD
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: UNI-OLC-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: June 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No