Sodium ferric gluconate complex in haemodialysis patients

A prospective evaluation of long-term safety

Beckie Michael, Daniel W. Coyne, Vaughn Wesley Folkert, Naomi V. Dahl, David G. Warnock

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background. A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. Results. Among 1412 enrolled patients at 54 centres, 1321 received 13 151 infusions of SFGC. Most doses (94.8%) were ≤125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. Conclusions. Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13 000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

Original languageEnglish (US)
Pages (from-to)1576-1580
Number of pages5
JournalNephrology Dialysis Transplantation
Volume19
Issue number6
DOIs
StatePublished - Jun 2004

Fingerprint

Renal Dialysis
Safety
Angiotensin-Converting Enzyme Inhibitors
ferric gluconate
gluconic acid
Enzyme Therapy
Pruritus
Vasodilation
Hypotension
Outpatients
Placebos
Research Personnel
Incidence

Keywords

  • Haemodialysis
  • Intravenous iron
  • Iron deficiency
  • Iron dextran sensitivity
  • Sodium ferric gluconate complex

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

Cite this

Sodium ferric gluconate complex in haemodialysis patients : A prospective evaluation of long-term safety. / Michael, Beckie; Coyne, Daniel W.; Folkert, Vaughn Wesley; Dahl, Naomi V.; Warnock, David G.

In: Nephrology Dialysis Transplantation, Vol. 19, No. 6, 06.2004, p. 1576-1580.

Research output: Contribution to journalArticle

Michael, Beckie ; Coyne, Daniel W. ; Folkert, Vaughn Wesley ; Dahl, Naomi V. ; Warnock, David G. / Sodium ferric gluconate complex in haemodialysis patients : A prospective evaluation of long-term safety. In: Nephrology Dialysis Transplantation. 2004 ; Vol. 19, No. 6. pp. 1576-1580.
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abstract = "Background. A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4{\%}) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. Results. Among 1412 enrolled patients at 54 centres, 1321 received 13 151 infusions of SFGC. Most doses (94.8{\%}) were ≤125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9{\%}) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4{\%}) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2{\%}) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. Conclusions. Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13 000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.",
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T1 - Sodium ferric gluconate complex in haemodialysis patients

T2 - A prospective evaluation of long-term safety

AU - Michael, Beckie

AU - Coyne, Daniel W.

AU - Folkert, Vaughn Wesley

AU - Dahl, Naomi V.

AU - Warnock, David G.

PY - 2004/6

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N2 - Background. A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. Results. Among 1412 enrolled patients at 54 centres, 1321 received 13 151 infusions of SFGC. Most doses (94.8%) were ≤125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. Conclusions. Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13 000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

AB - Background. A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. Results. Among 1412 enrolled patients at 54 centres, 1321 received 13 151 infusions of SFGC. Most doses (94.8%) were ≤125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. Conclusions. Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13 000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

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KW - Intravenous iron

KW - Iron deficiency

KW - Iron dextran sensitivity

KW - Sodium ferric gluconate complex

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