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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT01663103
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years
* CKD stage III or IV (eGFR with the 4-variable Modified Diet Renal Disease (MDRD) prediction equation: 15-60 mL/min/1.73m2; stable renal function in the past 3 months)
* An elevated high sensitivity C-reactive protein (hs-CRP) of \> 2.0 mg/L and \<30 mg/L on at least 2 consecutive weekly determinations
* Urine protein excretion \< 5.0 g/24h estimated by a spot urine protein/creatinine ratio
* Ability to provide informed consent
Exclusion Criteria:
* Patients with advanced CKD requiring chronic dialysis
* Active infection (chronic or acute (within 3 months) or antibiotic therapy (w/in 1 mo); history of recurrent infection
* Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Expected to undergo living related transplant in next 6 months
* History of severe congestive heart failure (i.e., EF \< 35%)
* Hospitalization in the past month
* Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hsCRP or immune function
* Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months
* Known malignancy
* HIV, active, chronic hepatitis B as evidenced by HBsAg positive and HBsAb negative, or hepatitis C positive
* Woman who are pregnant, nursing or planning to become pregnant
* Body mass index (BMI) \>40 kg/m2
* Warfarin use (or other cytochrome P (CYP)450 substrates with a narrow therapeutic index) \[ok if do not participate in endothelial cell collection\]
* Taking medication(s) that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)
* Currently receiving or planning to receive live or inactivated vaccines
* Alcohol dependence or abuse
* Subjects at risk for tuberculosis (TB). Specifically, subjects with:
* Current clinical, radiographic or laboratory evidence of active TB at screening or latent TB that has not been previously treated
* A history of active TB within the last 3 years even if it was treated.
* A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type.
* Therapy for latent TB which has not been completed as per local guidelines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01663103
Study Brief:
Protocol Section:
NCT01663103