Health Condition 1: N185- Chronic kidney disease, stage 5 Health Condition 2: null- Patients with Chronic Kidney Disease (CKD) on Dialysis
Conditions
Interventions
Intervention1: ZYAN1 (Desidustat) Tablets: Dosage: 50 mg, 100 mg & 150 mg Frequency: single Dose, Route: Oral, Duration: 3 Days
Control Intervention1: NIL: NIL
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients diagnosed with CKD (stage V), aged 18 to 80 years, inclusive. 2. Current clinical diagnosis of anemia, characterized in hemoglobin levels >= 6.5 g/dL before the start of the study. 3. Diagnosed patients for dialysis/patients with history of dialysis (hemodialysis or peritoneal dialysis three times in a week) for at least three months before enrolment. 4. Patients must be on stable doses of ESA therapy within 4 weeks prior to enrollment ( 5. Estimated GFR <15 mL/min/1.73 m2
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. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or history of myocardial infarction prior to first dose with study drug. 4. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection. 5. Active infection at initiation of study. 6. History of renal transplant. 7. 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. 8. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine. 9. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.Timepoint: Day 0, Day 1 & Day 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) PK parameters 2) Urine parameters Timepoint: Dosing (day 0), day 1, check-out (day 2) | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Cadila Healthcare Ltd
Outcome results
None listed