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

N/ANot Yet RecruitingNCT07755683

Services Hospital, Lahore60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

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.

DaprodustatDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. Hemoglobin at presentation: 8.0-10 g/dL, serum ferritin \> 100 ng/mL at screening and transferrin saturation (TSAT) \> 20% at screening. Exclusion Criteria: 1. Clinically significant gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks 2. Pregnant, breast-feeding, not agreed to use contraception 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 (ALT OR AST \> 40 IU, hepatitis B or C) 5. Use of any experimental/investigational drug within 30 days of screening or know hypersensitivity against trial drugs 6. Active or high risk malignancy 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).

Outcomes

Primary Outcomes

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

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.