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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06218290
Recruitment Status : Active, not recruiting
First Posted : January 23, 2024
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Unicycive Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE January 3, 2024
First Posted Date  ICMJE January 23, 2024
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE December 15, 2023
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2024)		 Incidence of treatment-related AEs leading to discontinuation [ Time Frame: 4 weeks ]
Tolerability as assessed by incidence of treatment-related AEs leading to discontinuation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2024)
  • Adverse Drug Reactions [ Time Frame: up to 10 weeks ]
    To evaluate the safety of clinically effective doses of OLC
  • Maximum Plasma Concentration (Cmax) of Lanthanum [ Time Frame: up to 10 weeks ]
    To evaluate the pharmacokinetics (PK) of OLC
  • Area Under the Concentration-Time Curve (AUC) of Lanthanum [ Time Frame: up to 10 weeks ]
    To evaluate the pharmacokinetics (PK) of OLC
  • Time to Peak Plasma Concentration (Tmax) of Lanthanum [ Time Frame: up to 10 weeks ]
    To evaluate the pharmacokinetics (PK) of OLC
  • Elimination Half-Life (t1/2) of Lanthanum [ Time Frame: up to 10 weeks ]
    To evaluate the pharmacokinetics (PK) of OLC
  • Change from Baseline in Clinical Laboratory Tests [ Time Frame: Up to 10 weeks ]
    Hematology and Biochemistry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 11, 2024)		 Patient Satisfaction Questionnaire [ Time Frame: up to 10 weeks ]
Assessment of patient satisfaction with OLC treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease Requiring Chronic Dialysis
Intervention  ICMJE Drug: Oxylanthanum Carbonate
Phosphate Binder to Reduce Hyperphosphatemia
Other Name: OLC
Study Arms  ICMJE Experimental: All Patients
All patients with chronic kidney disease with hyperphosphatemia
Intervention: Drug: Oxylanthanum Carbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2024)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06218290
Other Study ID Numbers  ICMJE UNI-OLC-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: June 2024
Current Responsible Party Unicycive Therapeutics, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Unicycive Therapeutics, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Unicycive Therapeutics, Inc
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP