A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
Status:
Terminated
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10
subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses,
followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have
stable Hgb levels will start the washout period of one to eight weeks. During the washout
period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm
their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a
1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic
overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day
29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period,
the trial subjects will be observed for an additional 28 days to allow safety and
immunogenicity assessments.