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A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia.
Nephrol Dial Transplant. 2016 04; 31(4):646-55.ND

Abstract

BACKGROUND

Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia.

METHODS

The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4.

RESULTS

Iron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2).

CONCLUSIONS

Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients.

Authors+Show Affiliations

Salford Royal NHS Foundation Trust, Salford, UK.Hull and East Yorkshire Hospitals NHS Trust, Hull and Hull York Medical School, Kingston Upon Hull, UK.Pushpawati Singhaniya Research Institute, New Delhi, India.SMS Medical College Hospital, Jaipur, Rajasthan, India.Dialysis Centre Kamen, Kamen, Germany.3 Department of Medicine, Socio-Medical Centre East-Danube Hospital, Vienna, Austria.Pharmacosmos A/S, Holbaek, Denmark.Washington University School of Medicine, St. Louis, MO, USA.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26250435

Citation

Kalra, Philip A., et al. "A Randomized Trial of Iron Isomaltoside 1000 Versus Oral Iron in Non-dialysis-dependent Chronic Kidney Disease Patients With Anaemia." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 31, no. 4, 2016, pp. 646-55.
Kalra PA, Bhandari S, Saxena S, et al. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016;31(4):646-55.
Kalra, P. A., Bhandari, S., Saxena, S., Agarwal, D., Wirtz, G., Kletzmayr, J., Thomsen, L. L., & Coyne, D. W. (2016). A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 31(4), 646-55. https://doi.org/10.1093/ndt/gfv293
Kalra PA, et al. A Randomized Trial of Iron Isomaltoside 1000 Versus Oral Iron in Non-dialysis-dependent Chronic Kidney Disease Patients With Anaemia. Nephrol Dial Transplant. 2016;31(4):646-55. PubMed PMID: 26250435.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. AU - Kalra,Philip A, AU - Bhandari,Sunil, AU - Saxena,Sanjiv, AU - Agarwal,Dhananjai, AU - Wirtz,Georg, AU - Kletzmayr,Josef, AU - Thomsen,Lars L, AU - Coyne,Daniel W, Y1 - 2015/08/06/ PY - 2015/03/19/received PY - 2015/07/09/accepted PY - 2015/8/8/entrez PY - 2015/8/8/pubmed PY - 2017/7/19/medline KW - chronic kidney disease KW - iron isomaltoside 1000 KW - iron treatment SP - 646 EP - 55 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 31 IS - 4 N2 - BACKGROUND: Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia. METHODS: The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4. RESULTS: Iron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2). CONCLUSIONS: Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/26250435/A_randomized_trial_of_iron_isomaltoside_1000_versus_oral_iron_in_non_dialysis_dependent_chronic_kidney_disease_patients_with_anaemia_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfv293 DB - PRIME DP - Unbound Medicine ER -