Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
NCT ID: NCT00742716
Last Updated: 2014-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2008-10-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CTA018 Injection low dose
Low dose IV 3 times a week for 4 weeks
CTA018 Injection
Comparison of different dosages of drug
CTA018 Injection low to mid dose
low to mid dose IV 3 times a week for 4 weeks
CTA018 Injection
Comparison of different dosages of drug
CTA018 Injection mid to high dose
mid to high dose IV 3 times a week for 4 weeks
CTA018 Injection
Comparison of different dosages of drug
CTA018 Injection high dose
high dose IV 3 times a week for 4 weeks
CTA018 Injection
Comparison of different dosages of drug
Interventions
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CTA018 Injection
Comparison of different dosages of drug
Eligibility Criteria
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Inclusion Criteria
* 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
* Currently taking cytochrome P450 3A inhibitors and/or inducers
* Abnormal liver functions
18 Years
80 Years
ALL
No
Sponsors
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OPKO IP Holdings II, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Melnick, MD
Role: STUDY_DIRECTOR
OPKO Renal
Locations
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Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States
Western New England Renal & Transplant Associates (WNERTA)
Springfield, Massachusetts, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
U.S. Renal Care
Fort Worth, Texas, United States
Capital District Heatlth Authority: Centre for Clinical Research
Halifax, Nova Scotia, Canada
St. Joseph's Health Care London
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Hôpital Charles-Lemoyne
Greenfield Park, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Hospital de Verdun
Verdun, Quebec, Canada
Countries
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Other Identifiers
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CTA018-CL-2002
Identifier Type: -
Identifier Source: org_study_id
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