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

Phase

N/A

Condition

N/A

Treatment

Iron Sucrose injection

Ferric Carboxymaltose (FCM)

Clinical Study ID

NCT06994065

IRONEASE Trial

Ages 18-85
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 chronicinflammatory conditions like tuberculosis or ulcerative colitis

Study Design

Iron Sucrose injection

June 02, 2025

September 30, 2025

Study 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.

Connect with a study center

Sindh Institute of Urology and Transplantaion
Karachi, Sindh
Pakistan
Active - Recruiting

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