Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

NCT06830941 | Not Yet Recruiting Phase 4

• 1 other identifier: Iron isomaltoside-PD
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Anemia; Peritoneal Dialysis (PD)

Keywords

peritoneal dialysis; renal anemia; iron isomaltoside; iron treatment

Outcome Measures

Primary Outcomes (1)

• Changes in hemoglobin concentration from baseline to week 8

  Full blood count

  Screening period，Day 1，Week 1，Week 4，Week 8

Secondary Outcomes (5)

• Changes in hemoglobin concentration from baseline to week 4

  Screening period，Day 1，Week 1，Week 4

• Iron metabolism indices and reticulocyte count at week 8

  Screening period，Day 1，Week 1，Week 4，Week 8

• Iron metabolism indices and reticulocyte count at week 4

  Screening period，Day 1，Week 1，Week 4

• Compound cardiovascular adverse events at Week 8

  Through study completion, an average of 1 year

• Adverse Events

  Through study completion, an average of 1 year

Study Arms (2)

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.

Drug: Iron isomaltoside

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).

Drug: Ferrous succinate

Interventions

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.

Also known as: Intravenous iron isomaltoside

Iron isomaltoside Group

Ferrous succinate DRUG

Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.

Also known as: Oral ferrous succinate

Ferrous succinate Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
• Hemoglobin(Hb）≤110 g/L at screening phase
• Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
• No oral or intravenous iron use within 4 weeks prior to screening.
• No hypoxia-inducible factor prolyl hydroxylase inhibitor（HIF-PHI）used or other erythropoiesis-stimulating agent（ESA）except for erythropoietin (EPO) used in the past 4 weeks prior to screening
• Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.
• Willing to participate and signed the informed consent form

You may not qualify if:

• Anemia predominantly caused by other diseases rather than renal diseases according to the investigator's judgement. (eg. bleeding, hematological diseases, anemia due to autoimmune diseases)
• History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
• Anemia due to lack of folate or vitamin B12：folate\<6.8nmol/L（3ng/ml）and(or) Vitamin B12\<74pmol/L（100pg/ml）at screening phase
• Histories of serious allergies to iron
• Obvious liver dysfunction：ALT\>3×ULN and/or AST\>3×ULN，or total bilirubin\>1.5×ULN
• Active acute or chronic infection(clinically diagnosed)
• Uncontrolled secondary hyperparathyroidism：PTH or iPTH\>9×ULN；
• History of malignancy within 5 years
• Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period
• NYHA grade III or IV of congestive heart failure or severe arrythmia(including ventricular tachycardia, ventricular fibrillation, AV-block III etc.) within 6 months before screening
• Pregnant or during lactation period or not willing to get contraception
• Planning to receive renal transplantation within 2 months
• Accepted blood transfusion within 3 months.
• Serum ferritin，SF\>500 μg/L
• Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period

Sponsors & Collaborators

• Xie Jingyuan, MD: lead
• RenJi Hospital: collaborator
• Songjiang Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Chinese People's Liberation Army No 455 Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Related Publications (18)

• 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.

  PMID: 26250435 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.

  PMID: 25925701 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.

  PMID: 32049331 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.

  PMID: 23998966 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.

  PMID: 21439379 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.

  PMID: 33580972 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.

  PMID: 32220343 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.

  PMID: 34758368 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.

  PMID: 23252877 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.

  PMID: 22854645 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.

  PMID: 32041774 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.

  PMID: 21784829 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.

  PMID: 15086928 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.

  PMID: 23438972 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.

  PMID: 29336855 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.

  PMID: 15070217 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.

  PMID: 33421457 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.

  PMID: 32061315 BACKGROUND

MeSH Terms

Interventions

iron isomaltoside 1000; ferrous succinate

Central Study Contacts

Jingyuan Xie

CONTACT

+862164370045; nephroxie@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share