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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT01219959
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female patients 18 years of age or older
2. Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\]
3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. Diabetes Mellitus (Type 1 and 2)
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
7. Total Kt/V ≥ 1.7
Exclusion Criteria:
1. Blood Urea Nitrogen (BUN) \> 95 mg/dL
2. Exposure to Extraneal within 60 days of Screening
3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77mm Hg) at Screening
4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
5. Cardiovascular event within the last 30 days
6. Ongoing clinically significant congestive heart failure \[New York Heart Association (NYHA) class III or IV\]
7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
8. Receiving rosiglitazone maleate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01219959
Study Brief:
Protocol Section:
NCT01219959