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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01155388
Other study ID # AMAG-FER-CKD-252
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 17, 2011
Est. completion date June 24, 2014

Study information

Verified date March 2022
Source AMAG Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).


Description:

Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined. Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest. Randomization was stratified by the following age cohorts: 12 to <18 years, 6 to <12 years, 2 to <6 years, and 6 months to <2 years.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date June 24, 2014
Est. primary completion date June 24, 2014
Accepts healthy volunteers No
Gender All
Age group 6 Months to 17 Years
Eligibility Key Inclusion Criteria for this study include: 1. Males or females 6 months to <18 years of age 2. Nondialysis dependent CKD, including kidney transplant recipients 3. Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter (dL) and b) transferrin saturation level <20% 4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study Key Exclusion Criteria for this study include: 1. History of allergy to either oral or IV iron 2. Allergy to two or more classes of drugs 3. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test 4. Hemoglobin level =7.0 g/dL 5. Serum ferritin level >600 nanograms/milliliter

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ferumoxytol
Experimental: Ferumoxytol
Oral Iron
Active Comparator: Oral iron

Locations

Country Name City State
United States AMAG Pharmaceuticals, Inc. Waltham Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change In Hemoglobin From Baseline To Week 5 Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the sponsor to discontinue the combined AMAG FER-CKD-252 and AMAG FER-CKD-251 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets. Baseline, Week 5
Secondary Pharmacokinetics: Area Under The Curve Of Ferumoxytol Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets. Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose
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