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ORAL VERSUS IV IRON THERAPY IN PATIENTS WITH KIDNEY DISEASE

Phase 1
Conditions
Chronic kidney disease.
Anemia in chronic kidney disease
D63.1
Registration Number
IRCT20231003059605N1
Lead Sponsor
Pak Emirates Military Hospital Rawalpindi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
210
Inclusion Criteria

Inclusion criteria included all male and female patients over the age of 18 years
Not on hemodialysis or erythropoietin diagnosed as anemia with a baseline Hb of less than 13 g/dl in males and less than 12 g/dl in females
With established chronic kidney disease with a GFR (glomerular filtration rate) of less than 60ml/min for more than 90 days assessed using the CKD-EPI equation and/or hyper albuminuria with urine albumin ? 30 mg in 24 hours or urine albumin to creatinine ratio (ACR) ? 30 mg/g.

Exclusion Criteria

Exclusion criteria included patients on dialysis, erythropoietin or use of erythropoietin stimulating agents (ESAs) in the last 3 months
Patients with advanced liver, cardiac or ESKD (end-stage kidney disease)
Drug allergies to iron and its supplemental form during therapy or previous known history
Unwilling to be included in the study.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum iron levels. Timepoint: 4 weeks after starting therapy. Method of measurement: Blood levels.;Serum Hb. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels.;Serum Ferritin levels. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels.;Serum transferrin and TIBC levels. Timepoint: 4 weeks after therapy. Method of measurement: Blood levels.
Secondary Outcome Measures
NameTimeMethod
Constipation and diarrhea. Timepoint: During 4 weeks of therapy. Method of measurement: Patient history.;Allergy to iron supplementation. Timepoint: During 4 weeks of therapy. Method of measurement: Patient assessment weekly during treatment.
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