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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Failure; Chronic Renal Insufficiency
• Intervention / Treatment: Drug: CTA018 Injection

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V8
      • Capital District Heatlth Authority: Centre for Clinical Research
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care London
    • Toronto, Ontario, Canada, M5N 1W8
      • St. Michael's Hospital
    • Weston, Ontario, Canada, M9N 1N8
      • Humber River Regional Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hôpital Charles-LeMoyne
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Cœur de Montréal
    • Verdun, Quebec, Canada, H4G 2A3
      • Hospital de Verdun
• United States
  • Florida
    • Pembroke Pines, Florida, United States, 33028
      • Pines Clinical Research, Inc.
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Boise Kidney and Hypertension Institute
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107-1121
      • Western New England Renal & Transplant Associates (WNERTA)
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Southeast Renal Research Institute
  • Texas
    • Fort Worth, Texas, United States, 76105
      • U.S. Renal Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTA018 Injection low dose; Low dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection; Comparison of different dosages of drug
Experimental: CTA018 Injection low to mid dose; low to mid dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection; Comparison of different dosages of drug
Experimental: CTA018 Injection mid to high dose; mid to high dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection; Comparison of different dosages of drug
Experimental: CTA018 Injection high dose; high dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection; Comparison of different dosages of drug

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: OPKO IP Holdings II, Inc.
• Investigators: Study Director: Joel Melnick, MD, OPKO Renal

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: August 26, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin D; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Kidney Failure; Parathyroid Diseases; Hyperparathyroidism, Secondary; Hyperparathyroidism
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Diseases; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Kidney Failure, Chronic; Renal Insufficiency; Hyperparathyroidism, Secondary
• Other Study ID Numbers: CTA018-CL-2002