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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530114
• Other study ID #: 20070664
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2007
• Last updated: February 16, 2016
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Hyperphosphatemia
• Hyperphosphatemic
• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
• Placebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To describe a dose response for AMG 223		TREATMENT PERIOD	No
Secondary	To evaluate the safety and tolerability of AMG 223		ENTIRE STUDY	Yes

External Links

•   AmgenTrials clinical trials website