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

NCT00530114 | Completed Phase 2

• 1 other identifier: 20070664
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objectives of this study are the following:

1. 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. 2.To describe a dose response for AMG 223
3. 3.To evaluate the safety and tolerability of AMG 223

Conditions

End Stage Renal Disease; Chronic Kidney Disease; Hyperphosphatemic; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To describe a dose response for AMG 223

  TREATMENT PERIOD

• To evaluate the safety and tolerability of AMG 223

  ENTIRE STUDY

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

Drug: Placebo

AMG 223

EXPERIMENTAL

1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

Drug: AMG 223

Interventions

AMG 223 DRUG

1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

AMG 223

Placebo DRUG

1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: March 14, 2016

Record last verified: 2016-02