Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients

NCT06556134 | Completed Phase 4

• 1 other identifier: PREFER
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.

Conditions

Anemia of Chronic Kidney Disease

Keywords

hemoglobin; transferrin saturation; ferritin; liposomal iron; intravenous iron sucrose

Outcome Measures

Primary Outcomes (1)

• Hemoglobin elevation and its correction speed

  Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL.

  Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)

Secondary Outcomes (2)

• Ferritin serum levels

  Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)

• Transferrin saturation

  Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)

Study Arms (2)

GROUP IV

ACTIVE COMPARATOR

Group IV received intravenous iron-hydroxide sucrose complex (marketed as Fermed® 100mg), administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 month

Drug: Intravenous Iron Sucrose

GROUP OS

ACTIVE COMPARATOR

Group OS received one oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid (marketed as Lisofer® 30mg), for the same 3-month duration

Drug: Oral Iron

Interventions

Intravenous Iron Sucrose DRUG

Intravenous iron-hydroxide sucrose complex administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 months

Also known as: Fermed® 100mg

GROUP IV

Oral Iron DRUG

One oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid

Also known as: Lisofer® 30mg

GROUP OS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Withdrawal from the study occurs in the case of severe anemia needing an urgent blood transfusion or non-adherence and withdrawal of consent.

Sponsors & Collaborators

• Centre Hospitalier Hassan II - Fès: lead

Study Sites (1)

Nephrology, Dialysis, and Transplantation, Hassan II University Hospital

Fes, Fès-Meknes, 30050, Morocco

Location

Related Publications (3)

• Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13.

  PMID: 25395392 RESULT

• Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul.

  PMID: 36060352 RESULT

• Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.

  PMID: 24891437 RESULT

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Tariq Sqalli Houssaini, MD

  Laboratory of Epidemiology and Health Science Research, Sidi Mohammed Ben Abdellah University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 15, 2024
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: January 10, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)