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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00561093
Eligibility Criteria:
Inclusion Criteria:
* At least 3 months on maintenance hemodialysis,
* Last 3-month averaged serum albumin \<4.0 g/dl,
* Average monthly Kt/V\>1.2,
* Dialysis time between 3 and 5 hours,
* Functioning AV graft or fistula or tunnel catheter that will not switch for 6 months,
* Standardized dialysis treatment per DaVita protocol.
* In case the averaged 3-month is not \<4.0 g/dl but last month serum albumin \<4.0 g/dl (worsening hypoalbuminemia) patient will be qualified, if 3-month averaged nPNA \< 0.8 g/kg/day or a BMI \< 20 kg/m2.
Exclusion Criteria:
* Peritoneal dialysis
* Terminal illnesses with life expectancy\<6 months
* Maintenance hemodialysis less than 5 months
* Concurrent appetite stimulants
* Use of IDPN in the past 2-3 months
* Inability to follow and to comply with the instructions and guidelines
* Likelihood of pregnancy or intention to become pregnant
* Acute wasting condition or active systemic disease
* Pulse chemo therapy
* Non-compliance with dialysis treatment
* Dialysis catheter that may switch soon.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00561093
Study Brief:
Protocol Section:
NCT00561093