Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy

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.

• Roxadustat (Drug): Roxadustat 100 mg was administered orally three times per week for three months.
• Erythropoietin (Drug): Recombinant erythropoietin 4000 IU was administered by subcutaneous injection twice weekly for three months.

Primary outcomes

• Change in Hemoglobin Level From Baseline to 3 Months [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.

Secondary outcomes

• Hemoglobin Response at 3 Months [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.

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

Age 18 to 75 years. Confirmed type 1 or type 2 diabetes mellitus. Chronic kidney disease stage 3a, 3b, 4, or 5, based on estimated glomerular filtration rate calculated using the 2021 CKD-EPI creatinine equation.

Anaemia, defined as haemoglobin <13.0 g/dL in males and <12.0 g/dL in females. Treatment-naive to erythropoiesis-stimulating agents or no erythropoiesis-stimulating agent treatment during the previous 4 weeks.

Exclusion Criteria:

Blood transfusion within the previous 8 weeks. Active infection. Malignancy. Active inflammatory disease. History of thromboembolic events. Uncontrolled hypertension. Pregnancy or breastfeeding. Known hypersensitivity to roxadustat or erythropoietin. Participation in another interventional study within the previous 30 days.