Clinical trial NCT00530114: Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Chronic Kidney Disease
Hyperphosphatemic
Kidney Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: TREATMENT PERIOD
Secondary outcomes:
measure: To describe a dose response for AMG 223
timeFrame: TREATMENT PERIOD
measure: To evaluate the safety and tolerability of AMG 223
timeFrame: ENTIRE STUDY
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: