MedTrace Logo

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

NCT07755683 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-10

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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

Daprodustat

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.

Sponsors & Collaborators

  • Services Hospital, Lahore

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755683 on ClinicalTrials.gov