An interventional study of Roxadustat and Erythropoietin in Diabetic Nephropathy, Anemia and Chronic Kidney Disease, sponsored by Hanzla Arshad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Hanzla Arshad · Not applicable, Interventional, and Treatment
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.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's enrollment of 64 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Hanzla Arshad is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 calculated using the 2021 CKD-EPI creatinine equation.
Anaemia, defined as \<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. . Active inflammatory disease. History of thromboembolic events. Uncontrolled hypertension. Pregnancy or breastfeeding. Known to roxadustat or erythropoietin. Participation in another interventional study within the previous 30 days.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received roxadustat 100 mg orally three times per week for three months.
Drug: Roxadustat
Participants received recombinant erythropoietin 4000 IU by subcutaneous injection twice weekly for three months.
Drug: Erythropoietin
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.
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
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Roxadustat
Hanzla Arshad