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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00530114
First received: September 13, 2007
Last updated: November 19, 2009
Last verified: November 2009

September 13, 2007
November 19, 2009
March 2008
November 2008   (final data collection date for primary outcome 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 [ Time Frame: TREATMENT PERIOD ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00530114 on ClinicalTrials.gov Archive Site
  • To describe a dose response for AMG 223 [ Time Frame: TREATMENT PERIOD ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of AMG 223 [ Time Frame: ENTIRE STUDY ] [ Designated as safety issue: Yes ]
  • To describe a dose response for AMG 223
  • To evaluate the safety and tolerability of AMG 223
Not Provided
Not Provided
 
Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Hyperphosphatemic
  • Kidney Disease
  • Drug: AMG 223
    1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
  • Drug: Placebo
    1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
  • Placebo Comparator: Placebo
    1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
    Intervention: Drug: Placebo
  • Experimental: AMG 223
    1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
    Intervention: Drug: AMG 223
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
February 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00530114
20070664
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP