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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00381602
Eligibility Criteria:
Inclusion Criteria:
* Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.
* Subjects who are 18 to 70 years of age.
* Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).
Exclusion Criteria:
* Subjects who have diabetes and are currently taking insulin.
* Subjects who have a history of or current significant central nervous system (CNS) disorders.
* Subjects who have active infection at baseline.
* Subjects who have active or unstable cardiac or arterial disease.
* Subjects who have uncontrolled tertiary hyperparathyroid condition.
* Subjects who have anemia.
* Subjects who have a history of hepatitis or current liver disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00381602
Study Brief:
Protocol Section:
NCT00381602