Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

NCT ID: NCT06830941

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2027-12-31

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.

Conditions

Renal Anemia; Peritoneal Dialysis (PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron isomaltoside Group

Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.

Group Type: EXPERIMENTAL

Iron isomaltoside

Intervention Type: 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.

Ferrous succinate Group

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

Group Type: ACTIVE_COMPARATOR

Ferrous succinate

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Ferrous succinate

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

Intervention Type: DRUG

Other Intervention Names

Intravenous iron isomaltoside; Oral ferrous succinate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Songjiang Hospital, Shanghai Jiao Tong University School of Medicine

UNKNOWN

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Chinese People's Liberation Army No 455 Hospital

OTHER_GOV

Sponsor Role: collaborator

Xie Jingyuan, MD

OTHER

Sponsor Role: lead

Responsible Party

Xie Jingyuan, MD

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Jingyuan Xie

Role: CONTACT

nephroxie@163.com

+862164370045 ext. 665272

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Other Identifiers

Iron isomaltoside-PD

Identifier Type: -

Identifier Source: org_study_id