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Not yet recruitingNCT07755683Updated Aug 10, 2026

Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis

An interventional study of Epoetin Alfa (drug) and Daprodustat in Chronic Kidney Disease (Stages 3b-5) and Anemia Associated With Chronic Kidney Disease, sponsored by Services Hospital, Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Services Hospital, Lahore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Kidney Disease (Stages 3b-5)
  • Anemia Associated With Chronic Kidney Disease

Keywords

  • Anemia
  • Daprodustat
  • Epoetin Alpha
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Services Hospital, Lahore is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age 18-65 years, either gender.
  2. Confirmed CKD stage 3, 4, or 5.
  3. Not currently receiving dialysis at time of screening.
  4. at presentation: 8.0-10 g/dL, serum ferritin > 100 ng/mL at screening and transferrin saturation (TSAT) > 20% at screening.

Exclusion criteria

Exclusion Criteria:

  1. gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks
  2. Pregnant, breast-feeding, not agreed to use
  3. Uncontrolled hypertension (>180/100 mmHg).
  4. Recent major cardiovascular event including acute coronary syndrome or stroke, or in the past 3 months, chronic liver disease ( OR AST > 40 IU, or C)
  5. Use of any experimental/ drug within 30 days of screening or know against trial drugs
  6. Active or high risk or treatment for malignancy with in the past 2 years.
  7. Uncorrected iron deficiency despite iron supplementations.
  8. Acute sepsis as evident by increase C-reactive protein (CRP), Total leukocyte count (TLC).
Terms in these criteria, in plain language(8)

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.

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).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A participants will be prescribed Epoetin alpha

    Group A, participants will be prescribed epoetin alpha with 50-100 IU/kg body weight.

    Drug: Epoetin Alfa (drug)

  • Active comparator
    Group B participants will be prescribed Daprodustat

    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.

    Drug: Daprodustat

Interventions

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 01 Month

  2. 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.

    Time frame: 01 Month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07755683
Lead sponsor
Services Hospital, Lahore
Responsible party
Dr Syed Umair Shah Sherazi (Principal Investigator, Services Hospital, Lahore) — Principal investigator
First posted
Aug 10, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Dr Syed Umair Shah Sherazi, MBBS
Contact
umairshahsuss@gmail.com
+9233048175506

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Epoetin Alfa

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