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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00179205
Eligibility Criteria:
Inclusion Criteria:
1. On hemodialysis for more than 6 months
2. Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
3. Suboptimal nutritional status identified by:
* Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:
* Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
* Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
* Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:
* Serum transferrin concentration less than 225 mg/dl
* Serum prealbumin concentration less than 32 mg/dl
Exclusion Criteria:
1. Active auto-immune, inflammatory or infectious disease
2. Documented malignancy within the last 12 months
3. Patients on unusual dietary restrictions
4. Life-expectancy less than 6 months
5. Inability to tolerate nutritional supplements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00179205
Study Brief:
Protocol Section:
NCT00179205