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

Primary Purpose

End Stage Renal Disease, Chronic Kidney Disease, Hyperphosphatemic

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AMG 223

Placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

AMG 223

Arm Description

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

Outcomes

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

Secondary Outcome Measures

To describe a dose response for AMG 223

To evaluate the safety and tolerability of AMG 223

Full Information

NCT ID

NCT00530114

First Posted

September 13, 2007

Last Updated

February 16, 2016

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00530114

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

Brief Summary

The primary objectives of this study are the following: 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 To describe a dose response for AMG 223 To evaluate the safety and tolerability of AMG 223

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Chronic Kidney Disease, Hyperphosphatemic, Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

AMG 223

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMG 223

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To describe a dose response for AMG 223

Time Frame

TREATMENT PERIOD

Title

To evaluate the safety and tolerability of AMG 223

Time Frame

ENTIRE STUDY

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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