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.
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
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- 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
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
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 group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | All 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.
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)
Adverse Drug Reactions
To evaluate the safety of clinically effective doses of OLC
Measured: up to 10 weeks
Maximum Plasma Concentration (Cmax) of Lanthanum
To evaluate the pharmacokinetics (PK) of OLC
Measured: up to 10 weeks
Area Under the Concentration-Time Curve (AUC) of Lanthanum
To evaluate the pharmacokinetics (PK) of OLC
Measured: up to 10 weeks
Time to Peak Plasma Concentration (Tmax) of Lanthanum
To evaluate the pharmacokinetics (PK) of OLC
Measured: up to 10 weeks
Elimination Half-Life (t1/2) of Lanthanum
To evaluate the pharmacokinetics (PK) of OLC
Measured: up to 10 weeks
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.
- First posted23 Jan 2024
- Study start15 Dec 2023
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Unicycive Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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 40658981Mathur 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