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NCT Number: NCT07755683

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

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.

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Key information

Conditions

Chronic Kidney Disease (Stages 3b-5) Anemia Anemia Associated With Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital Lahore Pakistan

Lahore, Punjab Province, 54000, Pakistan

Location contact

Dr Zahid Rafique, MBBS, FCPS

CONTACT

[email protected]

+923018454142

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Daprodustat

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Syed Umair Shah Sherazi, MBBS

CONTACT

[email protected]

+9233048175506

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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