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 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT01968759
Eligibility Criteria:
Inclusion Criteria:
* age \> 18 years;
* estimated glomerular filtration rate (GFR) by simplified MDRD formula \> 15 mL/min/1.73m2;
* 24-h urinary protein excretion rate ≥ 0.5 g/24hour;
* no concomitant treatment with phosphate binders;
* written informed consent
Exclusion Criteria:
* serum phosphate level \< 2.5 or \> 5.5 mg/dL;
* patients with serum PTH levels \>250 pg/mL without stable vitamin D (calcitriol or paricalcitol) or calcimimetics therapy from at least three months;
* serum calcium level \< 7.5 or \>10.5 mg/dL;
* history of congestive heart failure, myocardial infarction, cerebrovascular accident within the last 6 months;
* cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study;
* presence of, or predisposition to, intestinal or ileus obstruction or severe gastrointestinal motility disorder (like severe constipation);
* previous major gastrointestinal surgery;
* previous kidney transplantation;
* previous parathyroidectomy;
* concomitant treatment with antiacid and phosphate binders with aluminium, magnesium, calcium or lanthanum;
* pregnancy or breastfeeding;
* childbearing potential without reliable contraceptive methods during the whole study period;
* participation in any clinical trial using an investigational product or device during the 30 days preceding the first protocol visit;
* alcohol or drug (excluding tobacco) abuse ;
* inability to comply with the study procedures during the whole study period, legal incapacity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01968759
Study Brief:
Protocol Section:
NCT01968759