CompletedNot Applicable

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

Pakistan128 participantsStarted 2025-04-01

Plain-language 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

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline in hemoglobin concentration

Timeframe: Baseline, Day 28, Day 56

Change from baseline in Transferrin Saturation (TSAT)

Timeframe: Baseline, Day 28, Day 56

Change from baseline in serum Ferritin

Timeframe: Baseline, Day 28, Day 56

Trial details

NCT IDNCT06994065

SponsorSindh Institute of Urology and Transplantation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.