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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Iron isomaltoside
DrugIntravenous 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
DrugPatients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Iron isomaltoside GroupExperimental treatment 1 intervention
Group B: Ferrous succinate GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in hemoglobin concentration from baseline to week 8
Full blood count
Time frame
Screening period，Day 1，Week 1，Week 4，Week 8Secondary outcomes
1
Changes in hemoglobin concentration from baseline to week 4
Full blood count
Time frame
Screening period，Day 1，Week 1，Week 42
Iron metabolism indices and reticulocyte count at week 8
Iron metabolism indices and reticulocyte count
Time frame
Screening period，Day 1，Week 1，Week 4，Week 83
Iron metabolism indices and reticulocyte count at week 4
Iron metabolism indices and reticulocyte count
Time frame
Screening period，Day 1，Week 1，Week 44
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.
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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