Anemia Associated With Chronic Kidney Disease, Chronic Kidney Disease (Stages 3b-5)
Conditions
Keywords
Anemia, Daprodustat, Epoetin Alpha
Brief 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.
Interventions
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.
DRUGDaprodustat
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
Services Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Levels | 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. |
| Serum Ferritin Levels | 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. |
Countries
Pakistan
Contacts
CONTACTDr Syed Umair Shah Sherazi, MBBS
Outcome results
None listed