None listed
Conditions
Interventions
Intervention1: Ferric Carboxymaltose Injection: 200 mg diluted in 100 ml of 0.9% NaCl over a period of 30 minutes
after 1 hour of starting hemodialysis two to three times a week
Control Intervention1
Sponsors
EMCURE PHARMACEUTICALS LIMITED
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder Rate: Treatment responders will be defined as patients who attain an increase of &#8805;1.0 g/dl in Hb at 4 and 6 weeks from baseline.Timepoint: 4 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PCV, MCV, MCH, MCHC valuesTimepoint: 4 and 6 weeks;Change in serum ferritin levelsTimepoint: 4 and 6 weeks;Change in serum iron levelsTimepoint: 4 and 6 weeks;Change in TSAT valueTimepoint: 4 and 6 weeks | — |
Countries
India
Contacts
Public ContactDR BHAGWAT GUNALE
Emcure Pharmaceuticals Limited
Outcome results
None listed