A randomized controlled trial of oral versus intravenous iron in chronic kidney disease.
BACKGROUND
It is unknown whether intravenous iron or oral iron repletion alone can correct anemia associated with chronic kidney disease (CKD). We conducted a randomized multicenter controlled trial in adult anemic, iron-deficient non-dialysis CKD (ND-CKD) patients (>or=stage 3) not receiving erythropoiesis-stimulating agents (ESAs).


METHODS
The participants were randomized to receive either a sodium ferric gluconate complex (intravenous iron) 250 mg i.v. weekly x 4 or ferrous sulfate (oral iron) 325 mg t.i.d. x 42 days. Hemoglobin (Hgb), ferritin and transferrin saturation (TSAT) were measured serially, and the Kidney Disease Quality of Life (KDQoL) questionnaire was administered on days 1 and 43. The primary outcome variable was change from baseline (CFB) to endpoint in Hgb values.


RESULTS
Seventy-five patients were analyzed (intravenous iron n = 36, oral iron n = 39). CFB in Hgb was similar in the two groups (intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl, p = n.s.). However, the increase in Hgb was only significant with intravenous iron (p < 0.01). In comparison to oral iron, intravenous iron achieved greater improvements in ferritin (232.0 +/- 160.8 vs. 55.9 +/- 236.2 ng/ml, p < 0.001) and TSAT (8.3 +/- 7.5 vs. 2.9 +/- 8.8%, p = 0.007). Intravenous iron caused greater improvements in KDQoL scores than oral iron (p < 0.05). The most common side effect reported with intravenous iron was hypotension, while constipation was more common with oral iron.


CONCLUSIONS
Oral and intravenous iron similarly increase Hgb in anemic iron-depleted ND-CKD patients not receiving ESAs. Although in comparison to oral iron, intravenous iron may result in a more rapid repletion of iron stores and greater improvement in quality of life, it exposes the patients to a greater risk of adverse effects and increases inconvenience and cost.
Agarwal
Rajiv
R
Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, Indianapolis, IN 46202, USA. ragarwal@iupui.edu
Rizkala
Adel R
AR
Bastani
Bahar
B
Kaskas
Marwan O
MO
Leehey
David J
DJ
Besarab
Anatole
A
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004920:Erythropoiesis / Q000187:drug effects; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
D005290:Ferric Compounds; D006397:Hematinics; C035552:ferric gluconate