NCT01453634

Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.

Detailed description

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.

Conditions

• Stage 5 Chronic Kidney Disease (CKD)
• Secondary Hyperparathyroidism (SHPT)
• Hemodialysis (HD)

Interventions

Type	Name	Description
DRUG	Lunacalcipol 180	4 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.
DRUG	Lunicalcipol 270	8 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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-10-18
• Last updated: 2014-09-22