NCT01464931

Brief Summary

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 19, 2016

Completed
Last Updated

February 19, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

October 17, 2011

Results QC Date

December 14, 2015

Last Update Submit

January 22, 2016

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinically Significant Hypocalcemia

    Clinically significant hypocalcemia is defined as albumin-adjusted calcium \< 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.

    113 days

Secondary Outcomes (13)

  • Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria

    113 days

  • Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria

    113 days

  • Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria

    113 days

  • Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time

    Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113

  • Percent Change From Baseline in Serum Phosphorus Over Time

    Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113

  • +8 more secondary outcomes

Study Arms (1)

Denosumab

EXPERIMENTAL

Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.

Drug: Denosumab

Interventions

DenosumabDRUG

Adminstered by subcutaneous injection

Also known as: XGEVA, AMG 162
Denosumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects at least 18 years old with severe CKD (defined as creatinine clearance \< 30 mL/min at both screening assessments) and CKD requiring hemodialysis

You may not qualify if:

  • Subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Tempe, Arizona, 85284, United States

Location

Research Site

Denver, Colorado, 80230, United States

Location

Research Site

Pembroke Pines, Florida, 33028, United States

Location

Research Site

Meridian, Idaho, 83642, United States

Location

Research Site

Detroit, Michigan, 48236, United States

Location

Research Site

Orangeburg, South Carolina, 29118, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

November 4, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

February 19, 2016

Results First Posted

February 19, 2016

Record last verified: 2016-01

Locations

US(7)