ZYAN1(drug) is used for the treatment of anemia in chronic kidney disease patients.
- Conditions
- Health Condition 1: null- chronic kidney diseaseHealth Condition 2: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2017/05/008534
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in hemoglobin (Hb)Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method 1.No. of subject with Hb response at 6 weeks from baseline. <br/ ><br>2.Change from baseline in iron, total iron binding capacity (TIBC) and transferrin at 6 weeks. <br/ ><br>3.No. of subjects with adverse events (safety) <br/ ><br>4.Change from baseline in CRP at 6 weeks. <br/ ><br>5.Change from baseline in blood pressure at 6 weeks. <br/ ><br>6.Change from baseline in lipid parameters (LDL, TG) at 6 weeks. <br/ ><br>Timepoint: 6 weeks