2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223977

Enrollment

146

Registered

2005-09-22

Start date

2003-12-31

Completion date

2008-02-29

Last updated

2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Anemia.

Brief summary

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Interventions

DRUGSodium Ferric Gluconate Complex

125 mg weekly x 8 weeks

DRUGOral Iron

325 mg ferrous sulfate orally three times daily x 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, at least 18 years of age. * Received maintenance peritoneal dialysis therapy for at least 4 weeks. * Was expected to remain on peritoneal dialysis therapy for duration of study. * Had predetermined low hemoglobin and transferrin saturation (TSAT) levels. * Signed patient informed consent.

Exclusion criteria

* Had a predetermined serum levels of Ferritin and TSAT * Pregnant or lactating. * Had a serious concomitant medical disorder incompatible with participation in the study. * Had a known hypersensitivity to Ferrlecit or any of its components. * Unable to cooperate or comply with the protocol.

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin	Baseline to 5 weeks and 9 weeks	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

Secondary

Measure	Time frame	Description
Change From Baseline in Hematocrit (Hct)	Baseline to 5 weeks and 9 weeks	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Change From Baseline in Transferrin Saturation (TSAT).	Baseline to 5 weeks and 9 weeks	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Change From Baseline in Serum Ferritin.	Baseline to 5 weeks and 9 weeks	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Responders by Treatment Group	Baseline to 5 weeks and 9 weeks	Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.

Countries

Bulgaria, Canada, Croatia, India, Mexico, Poland, Russia, United States

Participant flow

Participants by arm

Arm	Count
Sodium Ferric Gluconate Complex 125 mg 125 mg sodium ferric gluconate weekly x 8 weeks	46
Sodium Ferric Gluconate Complex 250 mg 250 mg sodium ferric gluconate complex weekly x 4 weeks	58
Oral Iron 325 mg ferrous sulfate three times daily x 8 weeks	42
Total	146

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	7	10	0
Overall Study	Other	1	0	0
Overall Study	Protocol Violation	0	0	1
Overall Study	Withdrawal by Subject	1	1	2

Baseline characteristics

Characteristic	Sodium Ferric Gluconate Complex 125 mg	Sodium Ferric Gluconate Complex 250 mg	Oral Iron	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	12 Participants	5 Participants	7 Participants	24 Participants
Age, Categorical Between 18 and 65 years	34 Participants	53 Participants	35 Participants	122 Participants
Age Continuous	52.5 years STANDARD_DEVIATION 14.11	48.1 years STANDARD_DEVIATION 12.49	51.5 years STANDARD_DEVIATION 12.88	50.5 years STANDARD_DEVIATION 13.18
Region of Enrollment Bulgaria	1 participants	3 participants	1 participants	5 participants
Region of Enrollment Croatia	4 participants	8 participants	4 participants	16 participants
Region of Enrollment India	5 participants	7 participants	4 participants	16 participants
Region of Enrollment Mexico	6 participants	8 participants	9 participants	23 participants
Region of Enrollment Poland	8 participants	9 participants	7 participants	24 participants
Region of Enrollment Russian Federation	19 participants	19 participants	14 participants	52 participants
Region of Enrollment United States	3 participants	4 participants	3 participants	10 participants
Sex: Female, Male Female	23 Participants	30 Participants	27 Participants	80 Participants
Sex: Female, Male Male	23 Participants	28 Participants	15 Participants	66 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	16 / 46	20 / 58	12 / 42
serious Total, serious adverse events	3 / 46	13 / 58	7 / 42

Outcome results

Primary

Hemoglobin

Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection