Overview

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

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are the following: 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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Criteria
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