Anemia, Chronic Kidney Disease, Diabetic Nephropathy
Conditions
Keywords
Roxadustat, Erythropoietin, Renal Anemia, Diabetic Kidney Disease, Hemoglobin, CKD
Brief summary
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.
Detailed description
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.
Interventions
DRUGRoxadustat
Roxadustat 100 mg was administered orally three times per week for three months.
DRUGErythropoietin
Recombinant erythropoietin 4000 IU was administered by subcutaneous injection twice weekly for three months.
Sponsors
Hanzla Arshad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomized in a 1:1 ratio to two parallel treatment groups receiving either roxadustat or erythropoietin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Outcome results
None listed