| Trial ID: | L0458 |
| Source ID: | NCT06218290
|
| Associated Drug: |
Oxylanthanum Carbonate
|
| Title: |
A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease Requiring Chronic Dialysis
|
| Interventions: |
DRUG: Oxylanthanum Carbonate
|
| Outcome Measures: |
Primary: 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: 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: Patient Satisfaction Questionnaire, Assessment of patient satisfaction with OLC treatment, up to 10 weeks
|
| Sponsor/Collaborators: |
Sponsor: Unicycive Therapeutics, Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
106
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-15
|
| Completion Date: |
2024-05-29
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-24
|
| Locations: |
US Renal Care, Pine Bluff, Arkansas, 71603, United States|US Renal Care, Fort Myers, Florida, 33912, United States|US Renal Care, Gallup, New Mexico, 87301, United States|US Renal Care, Cheektowaga, New York, 14215, United States|US Renal Care, Toledo, Ohio, 43613, United States|US Renal Care, San Antonio, Texas, 78211, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06218290
|
