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
  Purpose

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

Condition Intervention Phase
End Stage Renal Disease
Chronic Kidney Disease
Hyperphosphatemic
Kidney Disease
Drug: AMG 223
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 167
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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
Experimental: AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
Drug: AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530114

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00530114     History of Changes
Other Study ID Numbers: 20070664
Study First Received: September 13, 2007
Last Updated: November 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014