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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure
• Interventions: Drug: CTA018 Injection

• Registration Number: NCT00742716
• Lead Sponsor: OPKO IP Holdings II, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Study Start: 2008-10
• Primary Completion: 2010-02
• Study Completion: 2010-06
• Status Verified: 2011-06
• Disposition First Submitted: 2014-10-30
• Disposition First Submitted QC: 2014-10-30
• Last Update Submitted: 2014-10-30
• Disposition First Posted: 2014-11-06
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTA018 Injection high dose	CTA018 Injection	high dose IV 3 times a week for 4 weeks
CTA018 Injection low dose	CTA018 Injection	Low dose IV 3 times a week for 4 weeks
CTA018 Injection low to mid dose	CTA018 Injection	low to mid dose IV 3 times a week for 4 weeks
CTA018 Injection mid to high dose	CTA018 Injection	mid to high dose IV 3 times a week for 4 weeks

Primary Outcome Measures

Name	Time	Method
To investigate the safety of CTA018 Injection	Throughout the study
To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection	Day 1 and 12 of each dose level

Secondary Outcome Measures

Name	Time	Method
To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection	Throughout the study
To determine the efficacy of CTA018 Injection to reduce serum iPTH	Throughout the study

Trial Locations

Locations (12)

Humber River Regional Hospital; 🇨🇦 Weston, Ontario, Canada

U.S. Renal Care; 🇺🇸 Fort Worth, Texas, United States

Western New England Renal & Transplant Associates (WNERTA); 🇺🇸 Springfield, Massachusetts, United States

St. Joseph's Health Care London; 🇨🇦 London, Ontario, Canada

Pines Clinical Research, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Southeast Renal Research Institute; 🇺🇸 Chattanooga, Tennessee, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hospital de Verdun; 🇨🇦 Verdun, Quebec, Canada

Boise Kidney and Hypertension Institute; 🇺🇸 Meridian, Idaho, United States

Hôpital Charles-Lemoyne; 🇨🇦 Greenfield Park, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Capital District Heatlth Authority: Centre for Clinical Research; 🇨🇦 Halifax, Nova Scotia, Canada