Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

Study Overview
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Brief Summary
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The primary objectives of this study are the following: 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 To describe a dose response for AMG 223 To evaluate the safety and tolerability of AMG 223

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

Conditions
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End Stage Renal Disease, Chronic Kidney Disease, Hyperphosphatemic, Kidney Disease

Intervention / Treatment
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* Drug: AMG 223
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maintenance hemodialysis 3 times a week for at least 3 months prior to screening 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: Previous intolerance leading to discontinuation of polymer-based phosphate binder therapy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally | Drug: Placebo<br>* 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally<br>|
| Experimental: AMG 223<br>1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally | Drug: AMG 223<br>* 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the 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 |  | TREATMENT PERIOD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe a dose response for AMG 223 |  | TREATMENT PERIOD | 
| To evaluate the safety and tolerability of AMG 223 |  | ENTIRE STUDY |