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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO IP Holdings II, Inc.

Criteria

Inclusion Criteria:

• Body mass index between 18 and 35

• On maintenance hemodialysis three times per week

• Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL

• Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL

• Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL

• Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL

• Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study

Exclusion Criteria:

• On bisphosphonates for at least three months prior to first dose of Study Drug

• Currently taking cytochrome P450 3A inhibitors and/or inducers

• Abnormal liver functions