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Completed

NCT Number: NCT07786168

Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy

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.

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Key information

Conditions

Diabetic Nephropathy Anemia Chronic Disease Chronic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Hospital

Lahore, 54810, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Change in Hemoglobin Level From Baseline to 3 Months

    Time frame: 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

  1. Hemoglobin Response at 3 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hanzla Arshad

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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