Sodium ferric gluconate complex in hemodialysis patients

Adverse reactions compared to placebo and iron dextran

Beckie Michael, Daniel W. Coyne, Steven Fishbane, Vaughn Folkert, Robert Lynn, Allen R. Nissenson, Rajiv Agarwal, Joseph W. Eschbach, Stephen Z. Fadem, J. Richard Trout, Jur Strobos, David G. Warnock, N. Franklin Adkinson, Daniel Batlle, Jose Cangiano, Jorge Diego, Jorge Diego, Pam Myirski, Chamberlain Obialo, Chika Oguagha & 4 others S. Noor Rahman, Steven Rosenblatt, Andrea J. Shaer, Marcia R. Silver

Research output: Contribution to journalArticle

154 Citations (Scopus)

Abstract

Background. Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. Methods. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. Results. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. Conclusion. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

Original languageEnglish (US)
Pages (from-to)1830-1839
Number of pages10
JournalKidney International
Volume61
Issue number5
DOIs
StatePublished - 2002

Fingerprint

Dextrans
Renal Dialysis
Iron
Placebos
Confidence Intervals
gluconic acid
ferric gluconate
Incidence
Anaphylaxis
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
Publications
Meta-Analysis
Prospective Studies
Safety

Keywords

  • Anaphylactoid reactions
  • Declaration of Helsinki
  • Hemodialysis
  • Iron deficiency
  • Iron dextran
  • Parenteral iron
  • Phase IV study design

ASJC Scopus subject areas

  • Medicine(all)
  • Nephrology

Cite this

Michael, B., Coyne, D. W., Fishbane, S., Folkert, V., Lynn, R., Nissenson, A. R., ... Silver, M. R. (2002). Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney International, 61(5), 1830-1839. https://doi.org/10.1046/j.1523-1755.2002.00314.x

Sodium ferric gluconate complex in hemodialysis patients : Adverse reactions compared to placebo and iron dextran. / Michael, Beckie; Coyne, Daniel W.; Fishbane, Steven; Folkert, Vaughn; Lynn, Robert; Nissenson, Allen R.; Agarwal, Rajiv; Eschbach, Joseph W.; Fadem, Stephen Z.; Trout, J. Richard; Strobos, Jur; Warnock, David G.; Adkinson, N. Franklin; Batlle, Daniel; Cangiano, Jose; Diego, Jorge; Diego, Jorge; Myirski, Pam; Obialo, Chamberlain; Oguagha, Chika; Rahman, S. Noor; Rosenblatt, Steven; Shaer, Andrea J.; Silver, Marcia R.

In: Kidney International, Vol. 61, No. 5, 2002, p. 1830-1839.

Research output: Contribution to journalArticle

Michael, B, Coyne, DW, Fishbane, S, Folkert, V, Lynn, R, Nissenson, AR, Agarwal, R, Eschbach, JW, Fadem, SZ, Trout, JR, Strobos, J, Warnock, DG, Adkinson, NF, Batlle, D, Cangiano, J, Diego, J, Diego, J, Myirski, P, Obialo, C, Oguagha, C, Rahman, SN, Rosenblatt, S, Shaer, AJ & Silver, MR 2002, 'Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran', Kidney International, vol. 61, no. 5, pp. 1830-1839. https://doi.org/10.1046/j.1523-1755.2002.00314.x
Michael, Beckie ; Coyne, Daniel W. ; Fishbane, Steven ; Folkert, Vaughn ; Lynn, Robert ; Nissenson, Allen R. ; Agarwal, Rajiv ; Eschbach, Joseph W. ; Fadem, Stephen Z. ; Trout, J. Richard ; Strobos, Jur ; Warnock, David G. ; Adkinson, N. Franklin ; Batlle, Daniel ; Cangiano, Jose ; Diego, Jorge ; Diego, Jorge ; Myirski, Pam ; Obialo, Chamberlain ; Oguagha, Chika ; Rahman, S. Noor ; Rosenblatt, Steven ; Shaer, Andrea J. ; Silver, Marcia R. / Sodium ferric gluconate complex in hemodialysis patients : Adverse reactions compared to placebo and iron dextran. In: Kidney International. 2002 ; Vol. 61, No. 5. pp. 1830-1839.
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T1 - Sodium ferric gluconate complex in hemodialysis patients

T2 - Adverse reactions compared to placebo and iron dextran

AU - Michael, Beckie

AU - Coyne, Daniel W.

AU - Fishbane, Steven

AU - Folkert, Vaughn

AU - Lynn, Robert

AU - Nissenson, Allen R.

AU - Agarwal, Rajiv

AU - Eschbach, Joseph W.

AU - Fadem, Stephen Z.

AU - Trout, J. Richard

AU - Strobos, Jur

AU - Warnock, David G.

AU - Adkinson, N. Franklin

AU - Batlle, Daniel

AU - Cangiano, Jose

AU - Diego, Jorge

AU - Diego, Jorge

AU - Myirski, Pam

AU - Obialo, Chamberlain

AU - Oguagha, Chika

AU - Rahman, S. Noor

AU - Rosenblatt, Steven

AU - Shaer, Andrea J.

AU - Silver, Marcia R.

PY - 2002

Y1 - 2002

N2 - Background. Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. Methods. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. Results. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. Conclusion. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

AB - Background. Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. Methods. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. Results. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. Conclusion. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

KW - Anaphylactoid reactions

KW - Declaration of Helsinki

KW - Hemodialysis

KW - Iron deficiency

KW - Iron dextran

KW - Parenteral iron

KW - Phase IV study design

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