drugset / Trial / NCT06830941
Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients
Phase 4
Not yet recruiting
124 enrolled
Xie Jingyuan, MD
Chinese People's Liberation Army No 455 Hospital · collabRenJi Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabSongjiang Hospital, Shanghai Jiao Tong University School of Medicine · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. The main questions to answer are: * Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia. * If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. Participants will: * be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group). * Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total). * Patients will be followed up for 8 weeks.
Timeline
- Start
- 2025-02-15
- Primary completion
- 2027-02-09
- Completion
- 2027-12-31
Publications
- Background Kalra PA, Bhandari S, Saxena S, Agarwal D, Wirtz G, Kletzmayr J, Thomsen LL, Coyne DW. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016 Apr;31(4):646-55. doi: 10.1093/ndt/gfv293. Epub 2015 Aug 6.
- Background Bhandari S, Kalra PA, Kothari J, Ambuhl PM, Christensen JH, Essaian AM, Thomsen LL, Macdougall IC, Coyne DW. A randomized, open-label trial of iron isomaltoside 1000 (Monofer(R)) compared with iron sucrose (Venofer(R)) as maintenance therapy in haemodialysis patients. Nephrol Dial Transplant. 2015 Sep;30(9):1577-89. doi: 10.1093/ndt/gfv096. Epub 2015 Apr 28.
- Background Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.
- Background Futterer S, Andrusenko I, Kolb U, Hofmeister W, Langguth P. Structural characterization of iron oxide/hydroxide nanoparticles in nine different parenteral drugs for the treatment of iron deficiency anaemia by electron diffraction (ED) and X-ray powder diffraction (XRPD). J Pharm Biomed Anal. 2013 Dec;86:151-60. doi: 10.1016/j.jpba.2013.08.005. Epub 2013 Aug 14.
- Background Jahn MR, Andreasen HB, Futterer S, Nawroth T, Schunemann V, Kolb U, Hofmeister W, Munoz M, Bock K, Meldal M, Langguth P. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011 Aug;78(3):480-91. doi: 10.1016/j.ejpb.2011.03.016. Epub 2011 Mar 23.
- Background Auerbach M, Henry D, DeLoughery TG. Intravenous ferric derisomaltose for the treatment of iron deficiency anemia. Am J Hematol. 2021 Jun 1;96(6):727-734. doi: 10.1002/ajh.26124. Epub 2021 Feb 26.
- Background Auerbach M, Gafter-Gvili A, Macdougall IC. Intravenous iron: a framework for changing the management of iron deficiency. Lancet Haematol. 2020 Apr;7(4):e342-e350. doi: 10.1016/S2352-3026(19)30264-9.
- Background Bazeley JW, Wish JB. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Am J Kidney Dis. 2022 Jun;79(6):868-876. doi: 10.1053/j.ajkd.2021.09.017. Epub 2021 Nov 7.
- Background Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, Haya-Palazuelos J, Ciria-Recasens M, Manasanch J, Perez-Edo L. Tolerability of different oral iron supplements: a systematic review. Curr Med Res Opin. 2013 Apr;29(4):291-303. doi: 10.1185/03007995.2012.761599. Epub 2013 Feb 6.
- Background Drueke TB, Parfrey PS. Summary of the KDIGO guideline on anemia and comment: reading between the (guide)line(s). Kidney Int. 2012 Nov;82(9):952-60. doi: 10.1038/ki.2012.270. Epub 2012 Aug 1.
- Background Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.
- Background Molnar MZ, Mehrotra R, Duong U, Kovesdy CP, Kalantar-Zadeh K. Association of hemoglobin and survival in peritoneal dialysis patients. Clin J Am Soc Nephrol. 2011 Aug;6(8):1973-81. doi: 10.2215/CJN.01050211. Epub 2011 Jul 22.
- Background Li S, Foley RN, Collins AJ. Anemia, hospitalization, and mortality in patients receiving peritoneal dialysis in the United States. Kidney Int. 2004 May;65(5):1864-9. doi: 10.1111/j.1523-1755.2004.00584.x.
- Background Horl WH. Anaemia management and mortality risk in chronic kidney disease. Nat Rev Nephrol. 2013 May;9(5):291-301. doi: 10.1038/nrneph.2013.21. Epub 2013 Feb 26.
- Background Fishbane S, Spinowitz B. Update on Anemia in ESRD and Earlier Stages of CKD: Core Curriculum 2018. Am J Kidney Dis. 2018 Mar;71(3):423-435. doi: 10.1053/j.ajkd.2017.09.026. Epub 2018 Jan 11.
- Background Cheng CK, Chan J, Cembrowski GS, van Assendelft OW. Complete blood count reference interval diagrams derived from NHANES III: stratification by age, sex, and race. Lab Hematol. 2004;10(1):42-53.
- Background Yang C, Yang Z, Wang J, Wang HY, Su Z, Chen R, Sun X, Gao B, Wang F, Zhang L, Jiang B, Zhao MH. Estimation of Prevalence of Kidney Disease Treated With Dialysis in China: A Study of Insurance Claims Data. Am J Kidney Dis. 2021 Jun;77(6):889-897.e1. doi: 10.1053/j.ajkd.2020.11.021. Epub 2021 Jan 7.
- Background GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 200 mg | Oral |
| Subject | Iron isomaltoside 1000 | Unknown | 1000 mg | Intravenous |