Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
NCT ID: NCT00530114
Last Updated: 2016-03-14
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
167 participants
INTERVENTIONAL
2008-03-31
2009-02-28
Brief Summary
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1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
2. To describe a dose response for AMG 223
3. To evaluate the safety and tolerability of AMG 223
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Placebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Interventions
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AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Placebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Eligibility Criteria
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Inclusion Criteria
* Single pool Kt/V at least 1.2 or urea reduction ratio at least 65%
* Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening
* No change(s) in type or dose of non-investigational phosphate binder(s) for at least 1 month prior to screening
* Serum albumin \> 3.0 mg/dL at screening
* If applicable, an increase in serum phosphorus of greater than or equal to 1.5 mg/dL, and a serum phophorous level \> 5.5 mg/dL and less than or equal to 10 mg/dl during the washout period
* If applicable, stable doses (defined as no change in dose for at least 1 month prior to screening) of Vitamin D replacement, calcimimetic agents, or bedtime calcium supplements
* Willingness to avoid intentional changes in diet such as fasting or dieting
Exclusion Criteria
* History of noncompliance with phosphate binder therapy in the opinion of the investigator
* Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant
* Current use of antiarrhythmic or anti-seizure medication
* Active ethanol or drug dependence or abuse, excluding tobacco use
* A screening serum calcium (corrected for albumin) \< 8.4 mg/dL
* History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, major gastrointestinal surgery, or gastric/duodenal ulcers within 6 months prior to screening
* Subject is pregnant, breast feeding, or is of child bearing potential and is not using adequate contraceptive precautions
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s)
* Subject has experienced a myocardial infarction or major surgery (excluding vascular access surgery) within 3 months prior to screening
* Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of localized basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20070664
Identifier Type: -
Identifier Source: org_study_id
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