Trial Outcomes & Findings for A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) (NCT NCT00648167)

Last Updated: 2017-04-04

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

28 days

Results posted on

2017-04-04

Participant milestones
Measure	KRX-0502 Ferric Citrate
Overall Study STARTED	55
Overall Study Start Dose 4.5 g/Day	34
Overall Study Start Dose 6 g/Day	21
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	KRX-0502 Ferric Citrate
Overall Study Adverse Event	6
Overall Study unable to swallow tablets	1

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Baseline characteristics by cohort
Measure	KRX-0502 n=55 Participants Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
Age, Continuous	53.46 years STANDARD_DEVIATION 11.48 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Region of Enrollment United States	50 participants n=93 Participants
Region of Enrollment Puerto Rico	5 participants n=93 Participants

Timeframe: 28 days

Outcome measures
Measure	KRX-0502 (Ferric Citrate) n=55 Participants Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) Baseline	5.9 mg/dL Standard Deviation 1.4
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) Day 28	5.4 mg/dL Standard Deviation 1.4

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events
Measure	KRX-0502 n=55 participants at risk Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate) Intent-to-Treat (ITT)
Infections and infestations Liver infection	1.8% 1/55 • Number of events 1
Infections and infestations Methicillin - susceptible staphylococcus aureus bacteremia	1.8% 1/55 • Number of events 1
Psychiatric disorders Suicide attempt	1.8% 1/55 • Number of events 1
Cardiac disorders Worsened congestive heart failure	1.8% 1/55 • Number of events 1

Other adverse events
Measure	KRX-0502 n=55 participants at risk Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate) Intent-to-Treat (ITT)
Gastrointestinal disorders Stool color abnormality	61.8% 34/55
Gastrointestinal disorders Diarrhea	25.5% 14/55
Gastrointestinal disorders Constipation	20.0% 11/55
Gastrointestinal disorders Nausea	9.1% 5/55
Gastrointestinal disorders Vomiting	9.1% 5/55
Gastrointestinal disorders Bloating	7.3% 4/55
Gastrointestinal disorders Heartburn	7.3% 4/55
Gastrointestinal disorders Stomach pain or cramp	7.3% 4/55
Gastrointestinal disorders Increased appetite	5.5% 3/55

Keryx Biopharmaceuticals Inc

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