Chronic Kidney Disease (Stages 3b-5)NCT07755683
Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
A study testing Epoetin Alfa (drug) and Daprodustat in people with Chronic Kidney Disease (Stages 3b-5) and Anemia Associated With Chronic Kidney Disease, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
Anemia in CKD patients is mainly attributed to impaired kidney being unable to adequately respond to hypoxia and/or anaemia by inducing erythropoietin (EPO) production iron disorders, blood loss, shortened erythrocyte survival time and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease (Stages 3b-5), Anemia Associated With Chronic Kidney Disease
- What is being tested?
- Epoetin Alfa (drug) and Daprodustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, either gender.
- Confirmed CKD stage 3, 4, or 5.
- Not currently receiving dialysis at time of screening.
- Hemoglobin at presentation: 8.0-10 g/dL, serum ferritin > 100 ng/mL at screening and transferrin saturation (TSAT) > 20% at screening.
Who cannot join
- Clinically significant gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks
- Pregnant, breast-feeding, not agreed to use contraception
- Uncontrolled hypertension (>180/100 mmHg).
- Recent major cardiovascular event including acute coronary syndrome or stroke, or in the past 3 months, chronic liver disease (ALT OR AST > 40 IU, hepatitis B or C)
- Use of any experimental/investigational drug within 30 days of screening or know hypersensitivity against trial drugs
- Active or high risk malignancy or treatment for malignancy with in the past 2 years.
- Uncorrected iron deficiency despite iron supplementations.
- Acute sepsis as evident by increase C-reactive protein (CRP), Total leukocyte count (TLC).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Services Hospital Lahore Pakistan
Lahore, Punjab Province, 54000
Dr Zahid Rafique, MBBS, FCPS, +923018454142, zrafique68@gmail.com
About this study
Anemia in CKD patients is mainly attributed to impaired kidney being unable to adequately respond to hypoxia and/or anaemia by inducing erythropoietin (EPO) production iron disorders, blood loss, shortened erythrocyte survival time and inflammation. High mortality among patients with advanced renal failure is directly related to the severity of anemia and hypoalbuminemia, particularly within the first six months.4, 5 Currently, the main treatment modalities for anemia in CKD include injections of erythropoiesis stimulating agents (ESAs), iron supplementation, and blood transfusion. EPO resistance and iron refractory anemia require red blood cell transfusions.
The rationale of this study is to compare the effectiveness of daprodustat versus epoetin alpha on hemoglobin level in patients with chronic kidney disease not on hemodialysis. Literature showed that epoetin alpha has better effectiveness in improving hemoglobin level and curing anemia in CKD patients. But conflicting results have been osbevred showing no difference in both drugs. In routine, both drugs are recommended for anemia in non-dialysis CKD patients. This trial is planned to check the effect of Daprodustat in patients not undergoing dialysis is primarily to provide an effective, orally administered alternative to current injectable anemia treatments, which are associated with several limitations and safety concerns. The treatment strategies and effectiveness optimization for patients with chronic kidney disease complicated by anemia remain a key issue that urgently needs to be addressed.
- Being tested
- Epoetin Alfa (drug), Daprodustat
- Keywords
- Anemia, Daprodustat, Epoetin Alpha
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Alfa (drug)Drug
Group A, 30 participants will be prescribed epoetin alpha with 50-100 IU/kg body weight. All participants will be followed-up in OPD for one month. After one month, blood sample will be taken again and sent to the laboratory of the hospital for assessment of hemoglobin level and serum ferritin level.
DaprodustatDrug
Group B, 30 participants will be prescribed daprodustat as per KDIGO guideline 2mg to 4mg daily and will be titrated as per requirement with maximun dosage of 24mg per day.All patients will be followed-up in OPD for one month. After one month, blood sample will be taken again and sent to the laboratory of the hospital for assessment of hemoglobin level and serum ferritin level.
| Study group | Role | What they receive |
|---|---|---|
| Group A participants will be prescribed Epoetin alpha | Experimental | Group A, participants will be prescribed epoetin alpha with 50-100 IU/kg body weight. Receives: Drug: Epoetin Alfa (drug) |
| Group B participants will be prescribed Daprodustat | Active comparator | Group B participants will be prescribed Daprodustat 2mg to 4mg daily and will be titrated as per requirement with maximum dosage of 24mg per day. Receives: Drug: Daprodustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Levels
Hemoglobin levels (gm/dl) will be calculated at baseline and after 01 month of Interventions. Mean change in Hemoglobin levels will be calculated.
Measured: 01 Month
Serum Ferritin Levels
Serum Ferritin levels (ng/ml) will be calculated at baseline and after 01 month of intervention. Mean change in levels will be calculated.
Measured: 01 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 3b-5)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Syed Umair Shah Sherazi, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755683
- Sponsor's protocol ID
- 10
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
- ClinicalTrials.gov ID
- NCT07755683
- Acronym / sponsor ID
- 10
- Keywords
- Anemia, Daprodustat, Epoetin Alpha
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 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.
Anemia in CKD patients is mainly attributed to impaired kidney being unable to adequately respond to hypoxia and/or anaemia by inducing erythropoietin (EPO) production iron disorders, blood loss, shortened erythrocyte survival time and inflammation. High mortality among patients with advanced renal failure is directly related to the severity of anemia and hypoalbuminemia, particularly within the first six months.4, 5 Currently, the main treatment modalities for anemia in CKD include injections of erythropoiesis stimulating agents (ESAs), iron supplementation, and blood transfusion. EPO resistance and iron refractory anemia require red blood cell transfusions.
The rationale of this study is to compare the effectiveness of daprodustat versus epoetin alpha on hemoglobin level in patients with chronic kidney disease not on hemodialysis. Literature showed that epoetin alpha has better effectiveness in improving hemoglobin level and curing anemia in CKD patients. But conflicting results have been osbevred showing no difference in both drugs. In routine, both drugs are recommended for anemia in non-dialysis CKD patients. This trial is planned to check the effect of Daprodustat in patients not undergoing dialysis is primarily to provide an effective, orally administered alternative to current injectable anemia treatments, which are associated with several limitations and safety concerns. The treatment strategies and effectiveness optimization for patients with chronic kidney disease complicated by anemia remain a key issue that urgently needs to be addressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants will be prescribed Epoetin alpha | Experimental | Drug: Epoetin Alfa (drug)Group A, participants will be prescribed epoetin alpha with 50-100 IU/kg body weight. |
| Group B participants will be prescribed Daprodustat | Active comparator | Drug: DaprodustatGroup B participants will be prescribed Daprodustat 2mg to 4mg daily and will be titrated as per requirement with maximum dosage of 24mg per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, either gender.
- Confirmed CKD stage 3, 4, or 5.
- Not currently receiving dialysis at time of screening.
- Hemoglobin at presentation: 8.0-10 g/dL, serum ferritin > 100 ng/mL at screening and transferrin saturation (TSAT) > 20% at screening.
Key exclusion criteria (8 listed)
- Clinically significant gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks
- Pregnant, breast-feeding, not agreed to use contraception
- Uncontrolled hypertension (>180/100 mmHg).
- Recent major cardiovascular event including acute coronary syndrome or stroke, or in the past 3 months, chronic liver disease (ALT OR AST > 40 IU, hepatitis B or C)
- Use of any experimental/investigational drug within 30 days of screening or know hypersensitivity against trial drugs
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 |
|---|---|---|
| Epoetin Alfa (drug)Group A, 30 participants will be prescribed epoetin alpha with 50-100 IU/kg body weight. All participants will be followed-up in OPD for one month. After one month, blood sample will be taken again and sent to the laboratory of the hospital for assessment of hemoglobin level and serum ferritin level. | Drug | Group A participants will be prescribed Epoetin alpha |
| DaprodustatGroup B, 30 participants will be prescribed daprodustat as per KDIGO guideline 2mg to 4mg daily and will be titrated as per requirement with maximun dosage of 24mg per day.All patients will be followed-up in OPD for one month. After one month, blood sample will be taken again and sent to the laboratory of the hospital for assessment of hemoglobin level and serum ferritin level. | Drug | Group B participants will be prescribed Daprodustat |
Primary outcome
Hemoglobin Levels
Time frame: 01 Month
Hemoglobin levels (gm/dl) will be calculated at baseline and after 01 month of Interventions. Mean change in Hemoglobin levels will be calculated.
Serum Ferritin Levels
Time frame: 01 Month
Serum Ferritin levels (ng/ml) will be calculated at baseline and after 01 month of intervention. Mean change in levels will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease (Stages 3b-5)
Not yet recruitingObservational study
Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study
Dialysis, Chronic Kidney Disease (Stages 3b-5)
Not yet recruiting
Pistachio Consumption in Patients With Chronic Kidney Disease
Chronic Kidney Disease (Stages 3b-5)
RecruitingObservational study
Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
CKD, Chronic Kidney Disease (Stages 3b-5)
Active, not recruiting
Strategies to Transform Kidney Care and Improve Pursuit of Transplant
Kidney Disease, Kidney Transplant
Recruiting
Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
Chronic Kidney Disease (Stages 3b-5)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epoetin Alfa (drug) and Daprodustat in people with Chronic Kidney Disease (Stages 3b-5) and Anemia Associated With Chronic Kidney Disease, run by Services Hospital, Lahore 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Syed Umair Shah Sherazi, MBBS (+9233048175506, umairshahsuss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Levels (time frame: 01 Month). The study lists 2 primary outcomes in all. 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 10 Aug 2026.