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Chronic Kidney Disease Requiring Chronic DialysisPhase 2NCT06218290

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

A Phase 2 study testing Oxylanthanum Carbonate in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Unicycive Therapeutics, Inc at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxylanthanum Carbonate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
7 sitesUnited States
Study dates
15 Dec 2023to 29 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • US Renal Care

    Cheektowaga, New York, 14215

  • US Renal Care

    Fort Myers, Florida, 33912

  • US Renal Care

    Gallup, New Mexico, 87301

  • US Renal Care

    Pine Bluff, Arkansas, 71603

  • US Renal Care

    San Antonio, Texas, 78211

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • US Renal Care

    Toledo, Ohio, 43613

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Oxylanthanum Carbonate
Keywords
CKD, ESRD
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxylanthanum CarbonateDrug

    Also called OLC

    Phosphate Binder to Reduce Hyperphosphatemia

Study groups in NCT06218290
Study groupRoleWhat they receive
All PatientsExperimentalAll patients with chronic kidney disease with hyperphosphatemia
Receives: Drug: Oxylanthanum Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (6)

  1. Adverse Drug Reactions

    To evaluate the safety of clinically effective doses of OLC

    Measured: up to 10 weeks

  2. Maximum Plasma Concentration (Cmax) of Lanthanum

    To evaluate the pharmacokinetics (PK) of OLC

    Measured: up to 10 weeks

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

    To evaluate the pharmacokinetics (PK) of OLC

    Measured: up to 10 weeks

  4. Time to Peak Plasma Concentration (Tmax) of Lanthanum

    To evaluate the pharmacokinetics (PK) of OLC

    Measured: up to 10 weeks

  5. Elimination Half-Life (t1/2) of Lanthanum

    To evaluate the pharmacokinetics (PK) of OLC

    Measured: up to 10 weeks

  6. Change from Baseline in Clinical Laboratory Tests

    Hematology and Biochemistry

    Measured: Up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start15 Dec 2023
  3. Primary completion29 May 2024
  4. Study completion29 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218290
Sponsor's protocol ID
UNI-OLC-201
Status last verified
Jun 2024
First submitted
3 Jan 2024
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD

Publications

  • 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.

    PubMed 40658981

  • 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.

    PubMed 39617673

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxylanthanum Carbonate in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Unicycive Therapeutics, Inc at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related AEs leading to study drug discontinuation during the Maintenance Period. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06218290, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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