Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
NCT00742716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2014-11-06
Summary
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
Conditions
- Chronic Kidney Disease
- Secondary Hyperparathyroidism
- Chronic Renal Insufficiency
- Chronic Renal Failure
Interventions
- DRUG
-
CTA018 Injection
Comparison of different dosages of drug
Sponsors & Collaborators
-
OPKO IP Holdings II, Inc.
lead INDUSTRY
Principal Investigators
-
Joel Melnick, MD · OPKO Renal
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-06-30
Countries
- United States
- Canada
Study Locations
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