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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT04040959
Eligibility Criteria:
Inclusion Criteria:
* Age 35-80 years;
* Ability to provide informed consent;
* Willing to accept random assignment to condition;
* CKD stage III or IV (eGFR with the 4-variable MDRD prediction equation: 20-60 mL/min/1.73m2; stable renal function in the past 3 months);
* Blood pressure controlled to \<140/90 mmHg for the past 3 months;
* Body mass index \<40 kg/m2;
* Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study
Exclusion Criteria:
* Patients with advanced CKD requiring chronic dialysis;
* Significant co-morbid conditions that lead the investigator to conclude that life expectancy \< 1 year;
* History of severe congestive heart failure (i.e., ejection fraction \< 35%);
* Hospitalization in the past month;
* Proteinuria \> 5 g/day;
* Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months;
* Known malignancy;
* Woman who are pregnant, nursing or planning to become pregnant;
* Special classes of subjects considered vulnerable populations will not be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT04040959
Study Brief:
Protocol Section:
NCT04040959