Effect of oral liposomal iron for treatment of iron deficiency anaemia in CKD patients

Phase 4

Completed

• Conditions: Health Condition 1: null- iron deficiency anaemia in Chronic Kidney Disease

• Registration Number: CTRI/2016/11/007459
• Lead Sponsor: CBCI society for medical education

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: 0

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified