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Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120mg in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Impairment

Intervention: Denosumab (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This is an open-label, multiple-dose study where 30 CKD eligible subjects will receive multiple 120 mg doses of denosumab administered SC; one dose on Day 1 and one dose Day 29.

Clinical Details

Official title: An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of clinically significant hypocalcemia, defined as albumin-adjusted Ca < 7.0mg/dL or symptomatic hypocalcemia

Secondary outcome:

Incidence and severity of hypocalcemia, hypomagnesemia and hypophosphatemia as determined by CTCAE v.4.0 criteria

Laboratory values of albumin-adjusted calcium, magnesium, and phosphorus and their changes compared to baseline

Adverse events including clinically significant changes in vital signs, physical examinations, clinical laboratory tests, ECGs;

Serum denosumab and C-telopeptide (CTx) concentrations

Incidence of seroreactivity (or antibody positivity)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects at least 18 years old with severe CKD and CKD requiring hemodialysis

- Additional inclusion criteria apply

Exclusion Criteria:

- Subjects must have calcium, phosphate, and magnesium levels appropriate for their

condition and must not have other uncontrolled co-morbidities.

- Additional exclusion criteria apply

Locations and Contacts

Research Site, Tempe, Arizona 85284, United States

Research Site, Denver, Colorado 80230, United States

Research Site, Pembroke Pines, Florida 33028, United States

Research Site, Meridian, Idaho 83642, United States

Research Site, Detroit, Michigan 48236, United States

Research Site, Orangeburg, South Carolina 29118, United States

Research Site, San Antonio, Texas 78215, United States

Additional Information

AmgenTrials clinical trials website

Starting date: November 2011
Last updated: November 26, 2013

Page last updated: August 23, 2015

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