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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Songjiang Hospital, Shanghai Jiao Tong University School of Medicine | UNKNOWN |
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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:
Participants will:
This is a prospective multicenter randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of single dose intravenous iron isomaltoside comparing with daily oral ferrous succinate in the treatment of renal anemia among patients on peritoneal dialysis.
A total of 124 patients will be enrolled. The primary endpoint is hemoglobin change from baseline to week 8, the secondary endpoint is hemoglobin change from baseline to week 4. Other secondary endpoints include the results of iron metabolism, reticulocytes, composite cardiovascular events, laboratory and safety parameters. The expected result is that intravenous iron isomaltoside is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside Group | Experimental | Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline. |
|
| Ferrous succinate Group | Active Comparator | Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside | Drug | Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in hemoglobin concentration from baseline to week 8 | Full blood count | Screening period,Day 1,Week 1,Week 4,Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hemoglobin concentration from baseline to week 4 | Full blood count | Screening period,Day 1,Week 1,Week 4 |
| Iron metabolism indices and reticulocyte count at week 8 | Iron metabolism indices and reticulocyte count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyuan Xie | Contact | +862164370045 | 665272 | nephroxie@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26250435 | 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. | |
| 25925701 | Background |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| C022943 | ferrous succinate |
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| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Chinese People's Liberation Army No 455 Hospital | OTHER_GOV |
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|
| Ferrous succinate | Drug | Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks. |
|
|
| Screening period,Day 1,Week 1,Week 4,Week 8 |
| Iron metabolism indices and reticulocyte count at week 4 | Iron metabolism indices and reticulocyte count | Screening period,Day 1,Week 1,Week 4 |
| Compound cardiovascular adverse events at Week 8 | Recording and observation with the reference of clinical symptoms and the results of EKG, NT-proBNP, cardiac troponin, CK-MB and myoglobin etc. | Through study completion, an average of 1 year |
| Adverse Events | Recording and observation with the reference of clinical symptoms and the results of laboratory indices and other indices for safety | Through study completion, an average of 1 year |
| 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. |
| 32049331 | 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. |
| 23998966 | 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. |
| 21439379 | 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. |
| 33580972 | 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. |
| 32220343 | 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. |
| 34758368 | 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. |
| 23252877 | 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. |
| 22854645 | 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. |
| 32041774 | 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. |
| 21784829 | 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. |
| 15086928 | 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. |
| 23438972 | 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. |
| 29336855 | 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. |
| 15070217 | 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. |
| 33421457 | 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. |
| 32061315 | 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. |