Health Condition 1: null- iron deficiency anaemia in Chronic Kidney Disease
Conditions
Interventions
Control Intervention1: carboxymaltose iron: IV carboxymaltose iron, divided into two administrations of 500 mg mg diluted in 250 mL normal saline, infused every 4 weekly for 2 months
Sponsors
CBCI society for medical education
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-65 years, Estimated glomerular filtration rate (eGFR, Modification of Diet in Renal Disease equation) <=60 mL/min/1.73 m2, Hb levels <=12 g/dL,plasma ferritin levels <=100 ng/mL, transferrin saturation (TSAT) <=25%, parathormone (PTH) serum levels between 30and 300 pg/mL, according to the suggested values for kidney disease stage and calcium and phosphate plasma levels within their normal values (i.e. <10.5 and <4.5 mg/dL, respectively).
Exclusion criteria
Exclusion criteria: includes high-sensitivity C-reactive protein (hsCRP) levels >=5 mg/L, presence of inflammatory, infectious disease or surgical interventions in the last 3 months,haematological disorders, bleeding or blood transfusions in the last 6 months, malignancies, treatment with immunosuppressive drugs, severe malnutrition, concomitant severe liver or CV disease, chronic alcohol or drug abuse within the past 6 months,known hepatitis B or C infection, pregnant or lactating women. Pharmacological and non-pharmacological therapies will be prescribed to each patient to achieve the therapeutic targets in keeping with the current practice guidelines suggested by K/DOQI CKD for Stages 3â??5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary out come of the study will be defined as the change in Hb values from baseline to end of treatment (T3) in each group, the difference in the per cent of patients achieving an increase in Hb of â?¥0.6 g/dL at any study point between baseline and T3 in the two treatment groups and the change in Hb levels from T3 to T4Timepoint: 3 Months T0,T1,T2 and T3 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary out come will be defined as change in TSAT and ferritin from baseline to end of treatment and from T3 to completion of the study (T4).Timepoint: 3 Months T3 and T4 | — |
Countries
India
Contacts
Public ContactDr Renuka
St. Johns Medical College & Hospital
Outcome results
None listed