Trial Outcomes & Findings for A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease (NCT NCT01155388)

Last Updated: 2022-04-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

Baseline, Week 5

Results posted on

2022-04-28

Participant Flow

Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 (NCT01155375) and enrollment continued under Study AMAG-FER-CKD-251. Data is for the combined Study AMAG-FER-CKD-252 and Study AMAG-FER-CKD-251.The results for the combined studies are included in this record.

Participant milestones

Participant milestones
Measure	Ferumoxytol Participants received 1 of the following 2 ferumoxytol dose regimens: * Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.	Oral Iron Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Overall Study STARTED	8	6
Overall Study Received at Least 1 Dose of Study Drug	8	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ferumoxytol Participants received 1 of the following 2 ferumoxytol dose regimens: * Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.	Oral Iron Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Overall Study Adverse Event	1	0

Baseline Characteristics

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ferumoxytol n=8 Participants Participants received 1 of the following 2 ferumoxytol dose regimens: * Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.	Oral Iron n=6 Participants Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.2 years STANDARD_DEVIATION 1.65 • n=5 Participants	13.8 years STANDARD_DEVIATION 4.52 • n=7 Participants	14.6 years STANDARD_DEVIATION 2.93 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 5

Population: Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose

Population: The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.

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.

Outcome measures

Outcome data not reported

Adverse Events

Ferumoxytol

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Oral Iron

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ferumoxytol n=8 participants at risk Participants received 1 of the following 2 ferumoxytol dose regimens: * Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.	Oral Iron n=6 participants at risk Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Infections and infestations Acute gastroenteritis	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Metabolism and nutrition disorders Hyperkalemia	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.

Other adverse events

Additional Information

Medical Information

AMAG Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data has been received by Sponsor, the Site and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 120 days to allow Sponsor to protect its interests.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ferumoxytol n=8 participants at risk Participants received 1 of the following 2 ferumoxytol dose regimens: * Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.	Oral Iron n=6 participants at risk Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Cardiac disorders Ventricular flutter	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Gastrointestinal disorders Food poisoning	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
General disorders Pyrexia	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Immune system disorders Hypersensitivity	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Chronic sinusitis	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Nasopharyngitis	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Pharyngitis	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Pneumonia	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Urinary tract infection	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Infections and infestations Viral pharyngitis	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Injury, poisoning and procedural complications Procedural hypotension	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Injury, poisoning and procedural complications Procedural nausea	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Injury, poisoning and procedural complications Skin injury	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Investigations Residual urine volume decreased	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Metabolism and nutrition disorders Fluid retention	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Psychiatric disorders Sleep disorder	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	0.00% 0/6 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.
Vascular disorders Hypertension	0.00% 0/8 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.	16.7% 1/6 • Number of events 1 • Randomization up to 7 weeks (Follow-up) 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 adverse events for the combined studies are included in this record.