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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01323335
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 50-75 years
* BMI 23-30 kg/m(2)
* Estimated GFR \>60 mL/min
* Blessed mental score equal to or less than 3
* Ability to fully participate in an informed consent process
* For Trial A (UA versus Placebo): all participants should have UA\<6 mg/dL
* For Trial B (Rasburicase versus Placebo): all participants should have UA 6.0-10 mg/dL
EXCLUSION CRITERIA:
* History of hypersensibility or intolerance to Rasburicase and/or to Lithium
* Chronic Kidney Disease.
* History of kidney stones.
* History of asthma, atopic allergies, hemolytic or methemoglobinemia reactions
* History of unstable angina, cardiac arrhythmia, stroke or myocardial infarction within 3 months, open-heart surgery within 6 months of the study enrollment
* History of drug or alcohol dependence, or positive urine toxicology
* Past or present positive test for HBV, HCV or HIV (base on blood test).
* Glucose-6-Phosphate Dehydrogenase deficiency (G6PD-deficiency)
* History of gout
* Last menstruation occurred less than 1 year ago
* Unintentional or intentional weight loss of 5 kg in the previous 6 months
* Alcohol daily intake \>30 grams (more than 2 beers daily, more than 2 glass of wine or cocktail daily)
* Current smokers or former smokers (stopped smoking less than 1 year before)
* Blood pressure \> 150/90 mmHg
* Diabetes mellitus on dietary or pharmacological treatment
* Hb \<11.5 g/dL in women or \< 12.5 g/dL in men
* Acute infection/inflammation (CRP\>5 mcg/mL) for Trial A: UA versus Placebo, CRP \>10mcg/L for Trial B: -Rasburicase versus Placebo, or any clinical overt chronic infections including periodontal disease.
* Active liver disease or liver function tests greater than 2 times upper normal limit
* Self reported inflammatory joints or autoimmune diseases
* Treatment over the last 3 months with Allopurinol, Rasburicase
* Treatment over the last 3 months with Warfarin, Dicumarol, Theophylline, Statins
* Necessity of daily treatment with NSAID
* Current hormone replacement
* Ongoing glucocorticoids, corticosteroids, including prednisone and/or cortisone injections or inhalations. (topical steroid cream use and occasional corticosteroid administration over the last 3 months is acceptable)
* Current daily antioxidants or/and multivitamin supplementation or over the last month
* Life-threatening diseases including malignancies
* Recent Blood Donation (last 56 days)
* Any other reason that based on the PI's judgment requires exclusion from this study
* Inability to obtain venous access.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01323335
Study Brief:
Protocol Section:
NCT01323335