Safety and efficacy of sodium ferric gluconate complex in patients with chronic kidney disease

Atinder Panesar, Rajiv Agarwal

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated. Methods: Charts of 58 CKD veterans (glomerular filtration rate <80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed. Results: Mean Hgb level at baseline was 10.5 ± 1.4 (SD) g/dL (105 ± 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 ± 1.3 g/dL (101 ± 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83% of the rHuEPO-plus-SFGC group at 31 days compared with 60% at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 ± 0.9 g/dL (114 ± 9 g/L) in contrast to 12.4 ± 1.7 g/dL (124 ± 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case. Conclusion: Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia.

Original languageEnglish (US)
Pages (from-to)924-931
Number of pages8
JournalAmerican Journal of Kidney Diseases
Volume40
Issue number5
DOIs
StatePublished - Nov 1 2002

Fingerprint

Chronic Renal Insufficiency
Sucrose
Safety
Hemoglobins
Iron
Erythropoietin
Anemia
ferric gluconate
gluconic acid
Veterans
Glomerular Filtration Rate
Pharmaceutical Preparations

Keywords

  • Anemia
  • Chronic kidney disease (CKD)
  • Iron deficiency
  • Parenteral iron
  • Sodium ferric gluconate in sucrose (SFGC)
  • Time-to-event analysis

ASJC Scopus subject areas

  • Nephrology

Cite this

Safety and efficacy of sodium ferric gluconate complex in patients with chronic kidney disease. / Panesar, Atinder; Agarwal, Rajiv.

In: American Journal of Kidney Diseases, Vol. 40, No. 5, 01.11.2002, p. 924-931.

Research output: Contribution to journalArticle

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abstract = "Background: We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated. Methods: Charts of 58 CKD veterans (glomerular filtration rate <80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed. Results: Mean Hgb level at baseline was 10.5 ± 1.4 (SD) g/dL (105 ± 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 ± 1.3 g/dL (101 ± 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83{\%} of the rHuEPO-plus-SFGC group at 31 days compared with 60{\%} at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 ± 0.9 g/dL (114 ± 9 g/L) in contrast to 12.4 ± 1.7 g/dL (124 ± 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case. Conclusion: Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia.",
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AU - Agarwal, Rajiv

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N2 - Background: We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated. Methods: Charts of 58 CKD veterans (glomerular filtration rate <80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed. Results: Mean Hgb level at baseline was 10.5 ± 1.4 (SD) g/dL (105 ± 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 ± 1.3 g/dL (101 ± 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83% of the rHuEPO-plus-SFGC group at 31 days compared with 60% at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 ± 0.9 g/dL (114 ± 9 g/L) in contrast to 12.4 ± 1.7 g/dL (124 ± 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case. Conclusion: Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia.

AB - Background: We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated. Methods: Charts of 58 CKD veterans (glomerular filtration rate <80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed. Results: Mean Hgb level at baseline was 10.5 ± 1.4 (SD) g/dL (105 ± 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 ± 1.3 g/dL (101 ± 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83% of the rHuEPO-plus-SFGC group at 31 days compared with 60% at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 ± 0.9 g/dL (114 ± 9 g/L) in contrast to 12.4 ± 1.7 g/dL (124 ± 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case. Conclusion: Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia.

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KW - Sodium ferric gluconate in sucrose (SFGC)

KW - Time-to-event analysis

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