Iron Indices and Intravenous Ferumoxytol: Time to Steady State
This study has been completed.
Sponsor:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier:
NCT01148745
First received: June 21, 2010
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Anemia |
Drug: ferumoxytol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Iron Indices and Intravenous Ferumoxytol: Time to Steady State |
Resource links provided by NLM:
Further study details as provided by Dialysis Clinic, Inc.:
Primary Outcome Measures:
- Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize [ Time Frame: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration ] [ Designated as safety issue: No ]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:
- Transferrin Saturation (TSAT) [ Time Frame: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days. ] [ Designated as safety issue: No ]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 [ Time Frame: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14) ] [ Designated as safety issue: No ]Serum ferritin values were measured at all visits
| Enrollment: | 15 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Feraheme
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148745
Locations
| United States, New Jersey | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dialysis Clinic, Inc. |
| ClinicalTrials.gov Identifier: | NCT01148745 History of Changes |
| Other Study ID Numbers: | DCI-0001 |
| Study First Received: | June 21, 2010 |
| Results First Received: | July 19, 2011 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anemia Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic |
Iron Metabolism Disorders Metabolic Diseases Ferumoxytol Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013