| Trial ID: | L1572 |
| Source ID: | NCT01453634
|
| Associated Drug: |
Lunacalcipol 180
|
| Title: |
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
|
| Acronym: |
2007
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Stage 5 Chronic Kidney Disease (CKD)|Secondary Hyperparathyroidism (SHPT)|Hemodialysis (HD)
|
| Interventions: |
DRUG: Lunacalcipol 180|DRUG: Lunicalcipol 270
|
| Outcome Measures: |
Primary: Measure the intact parathyroid hormone (iPTH) levels following Lunacalcipol Injection, 3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment. | Secondary: Assess the safety of Lunacalcipol Injection, Criteria relating to serum levels of iPTH, Ca, and P will be reviewed by the Medical Monitor. If any of the criteria are observed, subjects will be discontinued from the study 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, subjects beyond the first 2 will not be dosed., 3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2013-07
|
| Results First Posted: |
|
| Last Update Posted: |
2014-09-22
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01453634
|
