Iron Indices and Intravenous Ferumoxytol: Time to Steady State

• Sponsor: Dialysis Clinic, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01148745
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: ferumoxytol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Iron Indices and Intravenous Ferumoxytol: Time to Steady State
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: ferumoxytol FDA approved drug	Drug: ferumoxytol; 510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection); Other Names: Feraheme

Outcome Measures

Primary Outcome Measures

1. Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize [pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration]

   TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.

Secondary Outcome Measures

1. Transferrin Saturation (TSAT) [7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.]

   Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100

2. Serum Ferritin [7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)]

   Serum ferritin values were measured at all visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days

• TSAT less than or equal to 25 percent

• Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)

• (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)

• Subjects who are able to read and write in English

• Subjects who have signed consent

Exclusion Criteria:

• Subjects who have been enrolled in a clinical trial within the past 30 days

• Subjects who have received IV iron within 4 weeks of the start of the study

• Serum ferritin greater than or equal to 1200 ng/dL

• Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL

• Evidence of iron overload

• Known hypersensitivity to ferumoxytol or any of its components

• Anemia caused by conditions other than iron deficiency

• Subjects with elective surgeries scheduled within the next 3 months

• Subjects with elective magnetic resonance procedure scheduled during the study period

• Subjects who have been hospitalized within the past 30 days (excluding vascular access care)

• Subjects who have received a blood transfusion in the past 30 days

• Subjects who are transfusion dependent

• (Female) Subjects who are pregnant or nursing

• Subjects with known inflammatory conditions which may affect serum ferritin

• Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)

• Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)

• Subjects with life expectancy less than 6 months

• Subjects who refuse to sign consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dialysis Clinic, Inc.	North Brunswick	New Jersey	United States	08902

Sponsors and Collaborators

• Dialysis Clinic, Inc.

Investigators

• Principal Investigator: Toros Kapoian, MD, DCI North Brunswick

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dialysis Clinic, Inc.
• ClinicalTrials.gov Identifier: NCT01148745
• Other Study ID Numbers: DCI-0001
• First Posted: Jun 22, 2010
• Last Update Posted: Mar 30, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Anemia, Iron-Deficiency; Ferrosoferric Oxide

Study Results

Participant Flow

Arm/Group Title	Ferumoxytol
Arm/Group Description	2 doses of 510 mg IV over 17 seconds separated by 3 days
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ferumoxytol
Arm/Group Description	2 doses of 510 mg IV over 17 seconds separated by 3 days
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 60%
>=65 years	6 40%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (14)
Sex: Female, Male (Count of Participants)
Female	4 26.7%
Male	11 73.3%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
Description	TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.
Time Frame	pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferumoxytol
Arm/Group Description	All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
Measure Participants	15
Number [weeks]	2

2. Secondary Outcome

Title	Transferrin Saturation (TSAT)
Description	Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100
Time Frame	7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferumoxytol 510 mg
Arm/Group Description	2 doses of 510 mg IV over 17 seconds separated by 3 days
Measure Participants	15
TSAT at day 7 (visit 5)	27.6
TSAT at day 14 (visit 8)	26.7
TSAT at day 21 (visit 11)	23.9
TSAT at day 28 (visit 14)	26.7

3. Secondary Outcome

Title	Serum Ferritin
Description	Serum ferritin values were measured at all visits
Time Frame	7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ferumoxytol
Arm/Group Description	2 doses of 510 mg IV over 17 seconds separated by 3 days
Measure Participants	15
Ferritin at day 7 (visit 5)	912
Ferritin at day 14 (visit 8)	713
Ferritin at day 21 (visit 11)	679
Ferritin at day 28 (visit 14)	670

Adverse Events

Arm/Group Title	Ferumoxytol
Arm/Group Description	2 doses of 510 mg IV over 17 seconds separated by 3 days
All Cause Mortality
	Ferumoxytol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ferumoxytol
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Ferumoxytol
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.