Health Condition 1: D631- Anemia in chronic kidney disease Health Condition 2: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Desidustat: Dose: 100 mg as a starting dose
Route :-Oral
Duration:-Three times per week for 24 week
Control Intervention1: Epoetin alfa: Dose: 50 IU/Kg as a starting dose
Route :-Sub
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to understand and give informed consent for participation. 2. Male or female patients diagnosed with CKD, Stage V-D (Dialysis) and age â�¥18 years at screening visit. 3. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive). 4. a) Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera�® for at least 8 weeks prior to screening visit. OR b) Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (â�¤30% of dose change). 5. Patients on hemodialysis (â�¥2 times in a week) for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent/temporary). 6. Patients with no planned change in dialysis modality and with no planned renal transplant during study period. 7. Left ventricular ejection fraction â�¥40% by echocardiogram prior to randomization. 8. Adequate serum ferritin ï�¾200 ng/mL and/or TSAT ï�¾20%. 9. No iron, folate or Vitamin B12 deficiency. 10. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.
Exclusion criteria
Exclusion criteria: 1. Red blood cell transfusion within 8 weeks prior to participating in the study. 2. History of previous or concurrent cancer. 3. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection. 4. Active infection at initiation of study. 5. History of renal transplant. 6. Uncontrolled hypertension (defined as SBP >180 mmHg or DBP >100 mmHg) at screening visit (before dialysis). 7. Patient on high rhEPO dose at screening visit. [High dose defined as an epoetin dose of â�¥450 IU/kg/week intravenous or â�¥ 300 IU/kg/week subcutaneous or a darbepoetin dose of â�¥1.5 �µg/kg/week subcutaneous]. 8. Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing. 9. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine. 10. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia. 11. Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding. 12. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Desidustat or Epoetin alfa or to any erythropoieisis-stimulating agent. 14. Pregnant and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hb levelsTimepoint: At week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| No Hb responders Timepoint: At week 12 and week 24;Percentage of time spent in target Hb rangeTimepoint: Week 12 and Week 24;Time to achieve target range Hb levelTimepoint: Week 12 and Week 24 | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Cadila Healthcare Limited
Outcome results
None listed