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

NCT ID: NCT06556134

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-01-10

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.

Detailed Description

The last two and a half decades have seen erythropoiesis-stimulating agents (ESAs) and iron therapy at the forefront of managing anemia in chronic kidney disease (CKD) patients. While ESAs have demonstrated significant efficacy in alleviating anemia in this context, recent large-scale randomized controlled trials in both non-dialysis and dialysis CKD patients have shed light on their limitations. Attempts to normalize hemoglobin (Hb) levels with ESAs have shown no significant cardiovascular benefits but have been associated with increased risks of adverse events such as stroke and venous thromboembolism.

Consequently, there has been a reduction in ESA prescription and an increase in blood transfusions, coupled with a notable rise in the use of iron therapy due to its role in addressing hypo responsiveness to ESAs.

Anemia stands as a common complication in CKD, significantly impacting cardiovascular health and quality of life. While renal erythropoietin production deficit remains a primary cause, iron deficiency plays a pivotal role in CKD-related anemia genesis. Iron deficiency, whether absolute or functional, alongside an inflammatory block, often seen in CKD patients, accounts for the main reasons behind hypo responsiveness to erythropoiesis-stimulating agents.

The recent shift in focus from ESA-centered treatment to iron therapy has prompted debates regarding the ideal route of iron administration, particularly in non-dialysis CKD patients. Despite the benefits of oral iron-cost-effectiveness and ease of administration-its usage remains limited due to poor gastrointestinal absorption and high adverse event rates. Conversely, concerns about IV iron revolve around potential kidney damage, infections, atherosclerosis promotion, and other adverse reactions.

Given these considerations, our study aims to compare the efficacy of oral liposomal iron against IV iron in treating anemia in non-dialysis CKD patients in terms of :

1. Martial status under treatment.

2. Hemoglobin level and its correction speed.

3. Therapeutic tolerance.

Conditions

Anemia of Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

GROUP IV

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

Group Type: ACTIVE_COMPARATOR

Intravenous Iron Sucrose

Intervention Type: 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

GROUP OS

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

Group Type: ACTIVE_COMPARATOR

Oral Iron

Intervention Type: DRUG

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

Interventions

Intravenous Iron Sucrose

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

Intervention Type: DRUG

Oral Iron

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

Intervention Type: DRUG

Other Intervention Names

Fermed® 100mg; Lisofer® 30mg

Eligibility Criteria

Exclusion Criteria

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

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

Sponsors

Centre Hospitalier Hassan II - Fès

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tariq Sqalli Houssaini, MD

Role: STUDY_DIRECTOR

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

Locations

Nephrology, Dialysis, and Transplantation, Hassan II University Hospital

Fes, Fès-Meknes, Morocco

Countries

Morocco

References

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.

Reference Type: RESULT

PMID: 25395392 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36060352 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24891437 (View on PubMed)

Other Identifiers

PREFER

Identifier Type: -

Identifier Source: org_study_id