Chronic Kidney Disease, End Stage Renal Disease, Hyperphosphatemic, Kidney Disease
Conditions
Brief 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
Interventions
DRUGAMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
DRUGPlacebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To describe a dose response for AMG 223 | TREATMENT PERIOD |
| To evaluate the safety and tolerability of AMG 223 | ENTIRE STUDY |
Outcome results
None listed