Secondary Hyperparathyroidism (SHPT) Clinical Trial
Official title:
A Randomized, Open Label, Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018) Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
This is a prospective, open-label, PD, safety, PK and efficacy study of Lunacalcipol
Injection. Approximately 12 subjects will be randomized into 1 of 2 treatment groups
receiving either 180 µg (n=4) or 270 µg (n=8) Lunacalcipol Injection in a 1:2 ratio,
respectively. All subjects are planned to receive a total of 11 doses of the study drug
given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often
than every other day.
Previously defined criteria relating to serum levels of iPTH, Ca, and P will be reviewed by
the Medical Monitor to determine subject safety. If any of the criteria are observed,
subjects will be discontinued from the study, receiving no further administration of the
study drug and will be followed for safety. Safety data will be reviewed by the Medical
Monitor for the first 2 subjects in the 270 µg group. If the first 2 subjects meet dose
group discontinuation criteria, including treatment emergent calciphylaxis,
treatment-emergent adverse events (TEAEs) related to elevated serum Ca levels, or a reported
death associated with elevated serum Ca levels or related to study drug, subjects beyond the
first 2 will not be dosed.
A Data and Safety Monitoring Board (DSMB) will be appointed to provide an independent
evaluation of all safety data, including all laboratory results and serious adverse events
(SAEs). The DSMB will conduct its review after 4 subjects in the 270 µg dose group have
completed at least 6 doses, at any time death is reported, or at the request of the DSMB.
The DSMB will also conduct an additional review at the End of Study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04064827 -
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
|
Phase 3 |