Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis (NCT07755683) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
Pakistan60 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).