Iron Deficiency Anemia
Conditions
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.
Interventions
DRUGferumoxytol
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)
Sponsors
Dialysis Clinic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Serum Ferritin | 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14) | Serum ferritin values were measured at all visits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferumoxytol 2 doses of 510 mg IV over 17 seconds separated by 3 days | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Ferumoxytol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferumoxytol | Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize | 2 weeks |
Secondary
Serum Ferritin
Serum ferritin values were measured at all visits
Time frame: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ferumoxytol | Serum Ferritin | Ferritin at day 14 (visit 8) | 713 g/mL |
| Ferumoxytol | Serum Ferritin | Ferritin at day 21 (visit 11) | 679 g/mL |
| Ferumoxytol | Serum Ferritin | Ferritin at day 7 (visit 5) | 912 g/mL |
| Ferumoxytol | Serum Ferritin | Ferritin at day 28 (visit 14) | 670 g/mL |
Secondary
Transferrin Saturation (TSAT)
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ferumoxytol | Transferrin Saturation (TSAT) | TSAT at day 7 (visit 5) | 27.6 percent |
| Ferumoxytol | Transferrin Saturation (TSAT) | TSAT at day 14 (visit 8) | 26.7 percent |
| Ferumoxytol | Transferrin Saturation (TSAT) | TSAT at day 21 (visit 11) | 23.9 percent |
| Ferumoxytol | Transferrin Saturation (TSAT) | TSAT at day 28 (visit 14) | 26.7 percent |