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RecruitingNot ApplicableNCT06994065

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

Sponsor

Sindh Institute of Urology and Transplantation

Enrollment

128 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

Interventions

DRUGFerric Carboxymaltose (FCM)

This study will dose each patient according to their calculated iron deficit through Ganozi formula Iron deficit(mg) = bodyweight(kg) x (target Hb - actual Hb) (g/dl) x 2.4 + Iron storage depot(mg)

DRUGIron Sucrose injection

This study will dose each patient according to their calculated iron deficit through Ganozi formula Iron deficit(mg) = bodyweight(kg) x (target Hb - actual Hb) (g/dl) x 2.4 + Iron storage depot(mg)

Locations(1)

Sindh Institute of Urology and Transplantaion

Karachi, Sindh, Pakistan

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NCT06994065