Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

February 13, 2025 updated by: Xie Jingyuan, MD

Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Intravenous iron isomaltoside
Active Comparator: Ferrous succinate Group
Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total).
Drug: Ferrous succinate
Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.
Other Names:
  • Oral ferrous succinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemoglobin concentration from baseline to week 8
Time Frame: Screening period，Day 1，Week 1，Week 4，Week 8
Full blood count
Screening period，Day 1，Week 1，Week 4，Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemoglobin concentration from baseline to week 4
Time Frame: Screening period，Day 1，Week 1，Week 4
Full blood count
Screening period，Day 1，Week 1，Week 4
Iron metabolism indices and reticulocyte count at week 8
Time Frame: Screening period，Day 1，Week 1，Week 4，Week 8
Iron metabolism indices and reticulocyte count
Screening period，Day 1，Week 1，Week 4，Week 8
Iron metabolism indices and reticulocyte count at week 4
Time Frame: Screening period，Day 1，Week 1，Week 4
Iron metabolism indices and reticulocyte count
Screening period，Day 1，Week 1，Week 4
Compound cardiovascular adverse events at Week 8
Time Frame: 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.
Through study completion, an average of 1 year
Adverse Events
Time Frame: 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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xie Jingyuan, MD

Collaborators

RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Songjiang Hospital, Shanghai Jiao Tong University School of Medicine
Chinese People's Liberation Army No 455 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

February 9, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron isomaltoside-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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