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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT00938561
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Older than 18 years of age.
* With and without known CKD - for the purpose of this study, CKD will be defined on the basis by prior diagnosis of CKD, urologic or kidney disease, known abnormal urinalysis, or history of having seen a nephrologist.
Exclusion Criteria:
* Currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months. Subjects with an eGFR \< 30 mL/min/1.73 m2 will not receive Magnevist during the study visit.
* Active pulmonary edema.
* Class III or IV congestive heart failure.
* History of urinary retention or current urinary incontinence.
* Inability to cease taking medications that affect creatinine levels (e.g., bactrim, cimetidine) for one week prior to the study visit.
* Inability to maintain a stable regimen of anti-inflammatory agents and angiotensin converting enzyme inhibitors for one week prior to study visit
* Current treatment with amiodarone or metformin.
* Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy.
* Inadequate venous access.
* End stage conditions such as cirrhosis.
* Active treatment for cancer.
* Progressive neurological diseases.
* Severe gastric immotility.
* Recent radiation exposure to γ-emitting isotope other than technetium
* Known allergy to any of the GFR markers, iodine, or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish or have never received contrast dye will be excluded from participation.
* Dermatitis herpetiformis.
* Hypocomplementemic vasculitis.
* Multinodal goiter.
* Graves' disease.
* Autoimmune thyroiditis.
* Cognitive or physical impairments that will prevent a subject from providing informed consent.
* History of mastectomy.
* Hemoglobin levels below 10 g/dL.
* Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00938561
Study Brief:
Protocol Section:
NCT00938561