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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530114
First Posted: September 17, 2007
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • To describe a dose response for AMG 223 [ Time Frame: TREATMENT PERIOD ]
  • To evaluate the safety and tolerability of AMG 223 [ Time Frame: ENTIRE STUDY ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530114


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00530114     History of Changes
Other Study ID Numbers: 20070664
First Submitted: September 13, 2007
First Posted: September 17, 2007
Last Update Posted: March 14, 2016
Last Verified: February 2016

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