Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Phase 4

Not yet recruiting

• Conditions: Renal Anemia; Peritoneal Dialysis (PD)
• Interventions: Drug: Iron isomaltoside; Drug: Ferrous succinate

• Registration Number: NCT06830941
• Lead Sponsor: Xie Jingyuan, MD

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study Start: 2025-02-15
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-02-09
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
2. Hemoglobin(Hb）≤110 g/L at screening phase
3. Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
4. No oral or intravenous iron use within 4 weeks prior to screening.
5. 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
6. Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.
7. Willing to participate and signed the informed consent form

Exclusion Criteria

1. 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)
2. History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
3. 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
4. Histories of serious allergies to iron
5. Obvious liver dysfunction：ALT>3×ULN and/or AST>3×ULN，or total bilirubin>1.5×ULN
6. Active acute or chronic infection(clinically diagnosed)
7. Uncontrolled secondary hyperparathyroidism：PTH or iPTH>9×ULN；
8. History of malignancy within 5 years
9. Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period
10. 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
11. Pregnant or during lactation period or not willing to get contraception
12. Planning to receive renal transplantation within 2 months
13. Accepted blood transfusion within 3 months.
14. Serum ferritin，SF>500 μg/L
15. Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period
16. Other situations not suitable for inclusion decided by researchers. Rescreening is allowed if it failed in the first time of screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron isomaltoside Group	Iron isomaltoside	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	Ferrous succinate	Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total).

Primary Outcome Measures

Name	Time	Method
Changes in hemoglobin concentration from baseline to week 8	Screening period，Day 1，Week 1，Week 4，Week 8	Full blood count

Secondary Outcome Measures

Name	Time	Method
Changes in hemoglobin concentration from baseline to week 4	Screening period，Day 1，Week 1，Week 4	Full blood count
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
Iron metabolism indices and reticulocyte count at week 4	Screening period，Day 1，Week 1，Week 4	Iron metabolism indices and reticulocyte count
Compound cardiovascular adverse events at Week 8	Through study completion, an average of 1 year	Recording and observation with the reference of clinical symptoms and the results of EKG, NT-proBNP, cardiac troponin, CK-MB and myoglobin etc.
Adverse Events	Through study completion, an average of 1 year	Recording and observation with the reference of clinical symptoms and the results of laboratory indices and other indices for safety