Trial Outcomes & Findings for A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia (NCT NCT02128074)

Last Updated: 2018-08-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-08-24

Participant milestones
Measure	KRX-0502 KRX-0502 (ferric citrate) KRX-0502: 1g tablets of KRX-0502
Overall Study STARTED	32
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	6

Withdrawal data not reported

A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

Baseline characteristics by cohort
Measure	KRX-0502 n=32 Participants KRX-0502 (ferric citrate) KRX-0502: 1g tablets of KRX-0502
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 12.47 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

Timeframe: 8 weeks

Outcome measures
Measure	KRX-0502 n=32 Participants KRX-0502 (ferric citrate) KRX-0502: 1g tablets of KRX-0502
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period Baseline	10.8 g/dL Standard Deviation 0.77
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period Week 8	11.1 g/dL Standard Deviation 0.81

Serious events: 2 serious events

Other events: 25 other events

Deaths: 1 deaths

Serious adverse events
Measure	KRX-0502 n=32 participants at risk KRX-0502 (ferric citrate) KRX-0502: 1g tablets of KRX-0502
General disorders Rib Fracture	3.1% 1/32 • 8 Weeks
General disorders Urinary Tract Infection	3.1% 1/32 • 8 Weeks
General disorders General Physical Health Deterioration	3.1% 1/32 • 8 Weeks
Cardiac disorders Cardiac Failure Chronic	3.1% 1/32 • 8 Weeks

Other adverse events
Measure	KRX-0502 n=32 participants at risk KRX-0502 (ferric citrate) KRX-0502: 1g tablets of KRX-0502
Gastrointestinal disorders Diarrhoea	28.1% 9/32 • 8 Weeks
Gastrointestinal disorders Faeces Discoloured	25.0% 8/32 • 8 Weeks
Gastrointestinal disorders Abdominal Pain	18.8% 6/32 • 8 Weeks
Gastrointestinal disorders Constipation	9.4% 3/32 • 8 Weeks
Gastrointestinal disorders Abdominal Discomfort	6.2% 2/32 • 8 Weeks
Gastrointestinal disorders Vomiting	6.2% 2/32 • 8 Weeks
Investigations Weight Decrease	6.2% 2/32 • 8 Weeks
Metabolism and nutrition disorders Hyperkalaemia	6.2% 2/32 • 8 Weeks
Metabolism and nutrition disorders Hypocalcaemia	6.2% 2/32 • 8 Weeks
Nervous system disorders Dizziness	6.2% 2/32 • 8 Weeks
Vascular disorders Hypotension	6.2% 2/32 • 8 Weeks

Keryx Biopharmaceuticals, Inc

Phone: 1-844-44-KERYX (844-445-3799)

Restriction type: GT60