Trial Outcomes & Findings for Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients (NCT NCT00224003)

NCT ID: NCT00224003

Last Updated: 2009-09-28

Results Overview

Change from baseline to 2 weeks after last Fe dose

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2009-09-28

Participant Flow

Participant milestones

Measure	Sodium Ferric Gluconate Complex
Overall Study STARTED	23
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Sodium Ferric Gluconate Complex
Overall Study Adverse Event	1
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	1
Overall Study unk	3

Baseline Characteristics

Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Baseline characteristics by cohort

Measure	Sodium Ferric Gluconate Complex n=23 Participants
Age, Categorical <=18 years	23 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	13.2 years STANDARD_DEVIATION 2.39 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Per protocol (completer) population

Change from baseline to 2 weeks after last Fe dose

Outcome measures

Measure	Sodium Ferric Gluconate Complex n=12 Participants
Serum Ferritin	26.7 ng/mL Standard Deviation 240.05

PRIMARY outcome

Timeframe: 14 weeks

Population: Per protocol (completer) population

Change from baseline to 2 weeks after last dose

Outcome measures

Measure	Sodium Ferric Gluconate Complex n=12 Participants
Transferrin Saturation	2.0 % Standard Deviation 11.67

SECONDARY outcome

Timeframe: 14 weeks

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary Hoel, RPh, PhD

Watson Laboratories, Inc

Phone: 801-588-6641

Email: gary.hoel@watson.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60