Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01737866
Eligibility Criteria:
Inclusion Criteria:
* Men or women ≥18 years of age
* Laboratory test values (clinical chemistry and hematology)within normal limits, (other than test values out of the normal range for subjects with CKD \[groups 1 and 3 through 5\]), or clinically acceptable to the investigator and sponsor at screening and day -3
* Free of any clinically significant disease or condition(s) (other than that consistent with CKD for subjects in groups 1 and 3 through 5) that require a physician's care and/or would interfere with the evaluations, procedures, or participation in the study per the investigator's discretion;
Exclusion Criteria:
* Subjects whose second MDRD eGFR result during the screening period is not within 10% of the first eGFR result
* Subjects who have received a functioning renal transplant within the past year
* Subjects with ESRD who do not have a functioning hemodialysis access
* Subjects with hemodynamic instability during hemodialysis
* Subjects whose renal insufficiency is due to active autoimmune renal disease
* Subjects with renal insufficiency or ESRD requiring hemodialysis and Troponin I \> upper limit of normal (ULN) at screening or day -3
* Subjects with history of heart disease or unstable angina within the last 3 months
* Subjects with uncontrolled diabetes (Hb1Ac \> 8%) and/or subjects who are able but unwilling to adhere to the required fasting intervals
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01737866
Study Brief:
Protocol Section:
NCT01737866