Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXie Jingyuan, MD

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Iron isomaltoside
  • Ferrous succinate

Treatment groups

124 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Xie Jingyuan, MD

Lead sponsor

Ruijin Hospital

Sponsor institution

RenJi Hospital

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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