Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients

Sindh Institute of Urology and Transplantation

Status: Enrolling

Conditions: Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Treatments: Drug: Ferric Carboxymaltose (FCM); Drug: Iron Sucrose injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06994065

IRONEASE Trial

Details and patient eligibility

About

The goal of this clinical trial is to learn if Ferric Carboxymaltose is a safe efficacious alternative to Iron Sucrose for treatment of Iron deficiency anemia in non-dialysis dependent chronic kidney disease patients. The main questions it aims to answer are:

• Does Ferric Carboxymaltose causes similar or higher rise in hemoglobin concentration and serum Ferritin and transferrin saturation
• What medical problems will participants have when receiving Ferric Carboxymaltose

Participants will:

• Be administered either Ferric Carboxymaltose or Iron Sucrose
• Visit the clinic at day 28 and 56 for checkup and tests
• Be monitored for any medical problem during and after infusion

Full description

Anemia is a common complication of chronic kidney disease with its prevalence increasing with disease progression. The major causes of anemia in patients who have CKD are iron and erythropoietin deficiency. For management of iron deficiency either oral or intravenous iron products are used. Currently Iron Sucrose is being used as drug of choice for intravenous iron replacement for treatment of iron deficiency anemia as standard of care in Pakistan.

Objective of this study is to compare Ferric Carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia.

This study will be conducted at the department of Nephrology, Sindh Institute of Urology and Transplantation (SIUT), Karachi, Sindh, Pakistan. Data will be collected after taking approval of Institutional review board and Ethical review Committee and informed written consent from the participants.

Participants will be enrolled by principal investigator. All participants will be randomized into two groups by sealed envelopes.

After enrollment, participants will be administered either Ferric Carboxymaltose or Iron Sucrose at daycare clinic of department, Dose will be according to calculated iron deficit though Ganozi formula. Iron deficit(mg) = bodyweight(kg) x (target hemoglobin - actual hemoglobin ) (g/dl) x 2.4 + Iron storage depot(mg).

Medical problems (adverse effects) will be monitored, noted and treated accordingly.

Laboratory parameters such as hemoglobin, serum ferritin and transferrin saturation will be checked at baseline and scheduled visits, which will be compared at the end of study.

After completion of data collection, data analysis will be done using Statistical package for social sciences 26.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients
• Between age 18-85 years
• Patients diagnosed with Chronic kidney disease having eGFR of less than 60 ml/kg/1.73m2 (not on maintenance dialysis)

Exclusion criteria

• Patients on maintenance dialysis
• Patients with concomitant B12 or folate deficiency
• Patients receiving ESA therapy
• Patients with prior Iron replacement therapy within preceding 2 weeks
• Patients receiving blood transfusions within preceding 3 months
• Pregnant Females
• Patients with Upper GI Bleeding
• Patients with history of hematologic disorders, active malignancy or chronic inflammatory conditions like tuberculosis or ulcerative colitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Ferric Carboxymltose (FCM)

Experimental group

Description:

Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Iron Sucrose (IS)

Experimental group

Description:

Participants will receive intravenous Iron Sucrose according to their Iron deficit

Treatment:

Drug: Iron Sucrose injection