This randomized controlled trial compared roxadustat with erythropoietin for the treatment of anaemia in patients with diabetic nephropathy and chronic kidney disease. A total of 64 patients aged 18 to 75 years were enrolled at the Department of Nephrology, Sheikh Zayed Hospital, Lahore, and randomly assigned in a 1:1 ratio to two treatment groups. Participants in the roxadustat group received roxadustat 100 mg orally three times per week, while participants in the erythropoietin group received recombinant erythropoietin 4000 IU subcutaneously twice weekly. Participants were followed for three months. The primary objective was to compare the change in haemoglobin level between the two treatment groups after treatment.
Anaemia is a common complication of chronic kidney disease and is particularly relevant in patients with diabetic nephropathy. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used for the treatment of renal anaemia, whereas erythropoietin is an established erythropoiesis-stimulating treatment. Direct comparative evidence between these treatments in patients specifically affected by diabetic nephropathy remains limited. This study was designed as a randomized controlled trial conducted in the Department of Nephrology, Sheikh Zayed Hospital, Lahore. Eligible patients had diabetes mellitus, chronic kidney disease stage 3a, 3b, 4, or 5, and anaemia. After enrolment, participants were randomly assigned using the lottery method to receive either roxadustat 100 mg orally three times weekly or recombinant erythropoietin 4000 IU subcutaneously twice weekly. Treatment and follow-up continued for three months. Haemoglobin was measured at baseline and again at the end of the follow-up period. The primary outcome was the change in haemoglobin level from baseline to the end of treatment. Haemoglobin response was defined as an increase in haemoglobin of at least 1.0 g/dL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Roxadustat 100 mg was administered orally three times per week for three months.
Recombinant erythropoietin 4000 IU was administered by subcutaneous injection twice weekly for three months.
Sheikh Zayed Hospital
Lahore, Pakistan
Change in Hemoglobin Level From Baseline to 3 Months
Change in hemoglobin was calculated as the hemoglobin level at the end of the three-month treatment period minus the baseline hemoglobin level. Hemoglobin was measured in g/dL.
Time frame: Baseline to 3 months
Hemoglobin Response at 3 Months
Hemoglobin response was defined as an increase in hemoglobin level of at least 1.0 g/dL from baseline to the end of the three-month follow-up period. The outcome was assessed as the number and percentage of participants achieving a hemoglobin response.
Time frame: 3 months
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