Health Condition 1: null- chronic kidney disease Health Condition 2: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: ZYAN1 tablet: Dosage:-100 mg/150 mg/200 mg Route:- Oral
Frequency :-alternate day Duration :-6 weeks
Control Intervention1: Placebo: Route:- Oral
Frequency :-alternate day Duration :-
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Men who agree to use adequate contraception when sexually active or women without childbearing potential. 2)Estimated GFR greater than 15 mL/min/1.73 m2. 3)Not on dialysis and not expected to begin dialysis during the treatment period of the study.
Exclusion criteria
Exclusion criteria: 1)Any erythropoieitin treatment within 4 weeks prior to participating in the study. 2)Intravenous iron within 10 days prior to participating in the study. 3)Red blood cell transfusion within 8 weeks prior to participating in the study. 4)History of previous or concurrent cancer 5)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin (Hb)Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.No. of subject with Hb response at 6 weeks from baseline. 2.Change from baseline in iron, total iron binding capacity (TIBC) and transferrin at 6 weeks. 3.No. of subjects with adverse events (safety) 4.Change from baseline in CRP at 6 weeks. 5.Change from baseline in blood pressure at 6 weeks. 6.Change from baseline in lipid parameters (LDL, TG) at 6 weeks. Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Deven Parmar
Cadila Healthcare Limited
Outcome results
None listed