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NCT07755683Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
4 Aug 2026
Start date
Sept 2026
Primary completion date
Feb 2027
Lead sponsor
Services Hospital, Lahore
NCT number
NCT07755683

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Sept 2026 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of any experimental/investigational drug within 30 days of screening or know hypersensitivity against trial drugs

Other illness

  • Clinically significant gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks
  • Uncontrolled hypertension (\>180/100 mmHg).
  • Active or high risk malignancy or treatment for malignancy with in the past 2 years.

Lab values

  • 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)
  • Acute sepsis as evident by increase C-reactive protein (CRP), Total leukocyte count (TLC).

Other

  • Pregnant, breast-feeding, not agreed to use contraception
  • Uncorrected iron deficiency despite iron supplementations.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Services Hospital Lahore Pakistan
Coordinator of this site? Confirm its status
LahorePakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.