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
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