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

Amgen

Status and phase

Completed

Phase 2

Conditions

Chronic Kidney Disease

Hyperphosphatemic

End Stage Renal Disease

Kidney Disease

Treatments

Drug: Placebo

Drug: AMG 223

Study type

Interventional

Funder types

Industry

Identifiers

20070664

Details and patient eligibility

About

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

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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