Diabetic NephropathyNCT07786168
Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy
A study testing Roxadustat and Erythropoietin in people with Diabetic Nephropathy and Anemia, run by Hanzla Arshad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy, Anemia, Chronic Kidney Disease
- What is being tested?
- Roxadustat and Erythropoietin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Nephropathy, Anemia, Chronic Kidney Disease
- Being tested
- Roxadustat, Erythropoietin
- Keywords
- Roxadustat, Erythropoietin, Renal Anemia, Diabetic Kidney Disease, Hemoglobin, CKD
- Medical subject headings
- Diabetic Nephropathies, Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Roxadustat 100 mg was administered orally three times per week for three months.
ErythropoietinDrug
Recombinant erythropoietin 4000 IU was administered by subcutaneous injection twice weekly for three months.
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat Group | Experimental | Participants received roxadustat 100 mg orally three times per week for three months. Receives: Drug: Roxadustat |
| Erythropoietin Group | Active comparator | Participants received recombinant erythropoietin 4000 IU by subcutaneous injection twice weekly for three months. Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Dec 2025
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to two parallel treatment groups receiving either roxadustat or erythropoietin.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanzla Arshad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanzla Arshad, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786168
- Sponsor's protocol ID
- TERC/SC/INT/2025/469
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07786168
- Acronym / sponsor ID
- TERC/SC/INT/2025/469
- Conditions
- Diabetic Nephropathy, Anemia, Chronic Kidney Disease
- Keywords
- Roxadustat, Erythropoietin, Renal Anemia, Diabetic Kidney Disease, Hemoglobin, CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hanzla ArshadUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to two parallel treatment groups receiving either roxadustat or erythropoietin.
| Arm | Type | Receives |
|---|---|---|
| Roxadustat Group | Experimental | Drug: RoxadustatParticipants received roxadustat 100 mg orally three times per week for three months. |
| Erythropoietin Group | Active comparator | Drug: ErythropoietinParticipants received recombinant erythropoietin 4000 IU by subcutaneous injection twice weekly for three months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatRoxadustat 100 mg was administered orally three times per week for three months. | Drug | Roxadustat Group |
| ErythropoietinRecombinant erythropoietin 4000 IU was administered by subcutaneous injection twice weekly for three months. | Drug | Erythropoietin Group |
Primary outcome
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.
1 secondary outcome
Hemoglobin Response at 3 Months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roxadustat and Erythropoietin in people with Diabetic Nephropathy and Anemia, run by Hanzla Arshad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Level From Baseline to 3 Months (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.