NCT00742716

Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease

An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: OPKO IP Holdings II, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	CTA018 Injection	Comparison of different dosages of drug

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2008-08-28
• Last updated: 2014-11-06

Locations

12 sites across 2 countries: United States, Canada