1. SAFETY AND EFFICACY OF IV SODIUM FERRIC GLUCONATE COMPLEX IN PATIENTS WITH CHRONIC KIDNEY DISEASE
Claudia Beals, MD
John Detesco
Erdal Sarac, MD FACP FASN
Department of Internal Medicine
St. Elizabeth Health Center

2. Introduction
Iron deficiency is common in Chronic Kidney Disease (CKD) patients
Occurs for multiple reasons (GI loss, frequent blood testing,etc)
To render IV iron therapy practical to CKD patients in a variety of settings, the range of iron doses and infusion rates should be both broad and safe.
National Kidney Foundation Kidney Disease Outcomes Quality Initiative defines anemia as a Hgb<11.0 g/dL which affects approximately 75% of Non-Dialysis Dependent (NDD) CKD patients in the US.

3. IV vs. Oral Adverse reactions? Iron overload?
Which one maintains iron stores?

4. Purpose
The purpose of this study was to compare efficacy and safety of IV sodium ferric gluconate with that of oral iron in NDD patients with chronic kidney disease (CKD) in an outpatient office setting.

5. Methods
Retrospective chart audit was undertaken on anemic patients being treated with iron (PO or IV) and ESP (Erythrocyte Stimulating Proteins) in a office setting.
Patients were administered IV iron if serum ferritin level was < 100 or serum iron saturation <15%.
Patients were treated with oral iron preparations if serum ferritin level was >100 or serum iron saturation >15%.
Intravenous Ferrlecit 125mg was infused at a rate of 60 minutes once a week for six weeks (total 750mg).
TIBC Ferritin, FE sat %, Hgb and Hct was compared to oral iron 325 mg TID at baseline in patients with CKD
Laboratory values were collected at baseline, eight weeks and again at 12 weeks
Iron studies for the two groups were compared

6. 30 40 50 60 70 80 90
Age 5 10 15 20
Frequency
Mean = 70.2
Std. Dev. =
N = 99

7. Χ2 = 1.43, p = 0.231

9. Baseline 8 weeks 12 weeks IV 42.3 + 4.1 72.3  6.8 76.7  5.8 Oral50
100
150
Iron, Serum baseline
Iron, Serum 8 weeks
Iron, Serum 12 weeks
Oral
n = 88 IV
n = 26
Baseline 8 weeks 12 weeks IV
  5.8
Oral
  3.2

10. TIBC Baseline 8 weeks 12 weeks
100
200
300
400
500
TIBC baseline
TIBC 8 weeks
TIBC 12 weeks
Oral
n = 88 IV
n = 26
TIBC Baseline 8 weeks 12 weeks
IV   19.9
Oral   6.8

11. Fe sat% Baseline 8 weeks 12 weeks
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
Iron Saturation baseline
Iron Saturation 8 weeks
Iron Saturation 12 weeks
Oral
n = 88 IV
n = 26
Fe sat% Baseline 8 weeks 12 weeks
IV   2.2
Oral   1.4

12. Ferritin Baseline 8 weeks 12 weeks
300
600
900
1200
1500
Ferritin, Serum baseline
Ferritin, Serum 8 weeks
Ferritin, Serum 12 weeks
Oral
n = 88 IV
n = 26
Ferritin Baseline 8 weeks 12 weeks
IV   55.9
Oral  126.0

13. Hgb Baseline 8 weeks 12 weeks
8.0
9.0
10.0
11.0
12.0
13.0
14.0
HGB baseline
HGB 8 weeks
HGB 12 weeks
Oral
n = 88 IV
n = 26
Hgb Baseline 8 weeks 12 weeks
IV   0.3
Oral   0.1

14. Hct Baseline 8 weeks 12 weeks
25.0
30.0
35.0
40.0
HCT baseline
HCT 8 weeks
HCT 12 weeks
Oral
n = 88 IV
n = 26
Hct   Baseline 8 weeks 12 weeks
IV   0.9
Oral   0.3

15. Conclusion
IV Sodium Ferric Gluconate was more efficacious in CKD patients than oral Fe.
High dose 750 mg of IV Sodium Ferric Gluconate can be safely administered as 125mg over 60 minutes without any severe Adverse Drug Reactions.
ESP requirement was similar in both IV and PO iron therapy groups.
Fe indices increased, with a dramatic increase in Hgb and Hct over the 12 week interval in IV therapy group.
Oral Fe did not demonstrate significant changes in Hgb and Hct levels

16. Discussion Safety issues
IV Sodium Ferric Gluconate does not require a test dose
no fatal adverse effects has ever been reported
oversaturation?

17. Discussion Efficacy IV vs. Oral IV iron better bioavailabilty
better patient adherence
Oral
poor bioavailabilty
ineffective erythropoesis
poor patient adherence

18. Questions?

19. References
1. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease.: Update Am. J Kidney Dis 37: S182-S (suppl 1)
2.Hudson JQ, Comstock TJ. Considerations for optimal Iron use for anemia due to chronic kidney disease. Clin. Therapeutics. 2001;23(10):
3.Matzke,G.R.: Intravenous iron supplementation in end-stage renal disease patients. Am. J Kidney Dis.1999; 33 (3):
4.Seligman, P.A., Dahl, N.V, Strobs, et al. Single-dose Pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects. Pharmcotherapy 2004;24(5):574-83
5.Fishbane,S, Wagner, J. Sodium ferric gluconate complex in the treatment of iron deficiency for patients on dialysis. Am J Kidney Dis. : In-depth review 2001; 37(5):
Bailie,G.R., Johnson, C.A., Mason, N.A. Parenteral Iron use in the management of anemia in end-stage renal disease patients. Am J Kidney Dis. : In-depth review 2000; 35 (1): 1-12