Clinical Study to evaluate efficacy and tolerability of Ferric Carboxymaltose Injectio

Phase 3

Completed

• Registration Number: CTRI/2010/091/001203
• Lead Sponsor: EMCURE PHARMACEUTICALS LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients aged between 18 to 65 years of age
Iron deficiency anemia (Hb &#8805; 7 g/dl to &#8804; 11 g/dl and either serum ferritin < 300 mcg/l or TSAT < 20%)
Clinically stable patients with anemia of hemodialysis dependent chronic kidney disease without a hospital admission due to renal decompensation during the 4 weeks prior to study inclusion.
Patients undergoing hemodialysis two to three times weekly.
Patients on stable dose of erythropoietin for last 4 weeks.
Patients providing written informed consent.
Females in reproductive age group practicing effective methods of contraception.

Exclusion Criteria

Serum ferritin > 500 mcg/l, TSAT > 50% or serum albumin <2.5 g/dl.
Known hypersensitivity to iron polysaccharide complexes, Iron Sucrose or Ferric Carboxymaltose.
Any other type of anemia.
Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
Significant cardiovascular disease (including myocardial infarction during the 6 months prior to study inclusion, congestive heart failure NYHA Class III or IV and poorly controlled hypertension).
Patients receiving phosphate binders containing aluminium (e.g. aluminium hydroxide).
Uncontrolled endocrinological or metabolic disorders including uncontrolled hyperparathyroidism.
Presence of any active infection.
Any malignancy.
Presence of active liver disease / HBV or HCV infection, HIV infection / AIDS, asthma, or rheumatoid arthritis.
Pregnancy and lactation.
History of alcohol / drug abuse.
Treatment with Oral / IV iron preparations or any investigational drug within 4 weeks prior to study enrollment.
Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified