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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01242904
Eligibility Criteria:
Inclusion Criteria:
1. Be able to provide informed consent
2. Age greater than 18 years
3. Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
4. Be APD patients who;
1. Can be managed with an icodextrin long dwell AND
2. Will use 4.25% and/or a 2.5% solution for at least one exchange overnight in at least 5 out of 7 days
5. Have residual urine volume \<800 ml/24 hours
6. Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.
Exclusion Criteria:
1. Scheduled Transplant in the next 1 year
2. Life expectancy \< 3 mo (estimated by physician)
3. Participating in other trial that could influence outcome of this trial
4. Known icodextrin allergy
5. Currently using non-Baxter PD solutions
6. Systolic blood pressure \< 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives
Supplementary Exclusion Criteria (post Run-in phase):
1\) Unsuccessfully completed 1 week run-in phase. Defined as:
1. Not using bimodal solution on 7 consecutive days during the run-in
2. Not tolerating the increased UF anticipated with the bimodal solution. Tolerating defined as:
i) Blood pressure drop below 90/50 on more than three occasions during a seven day period that cannot be corrected by reducing anti-hypertensives or other simple measures ii) Intolerable feeling of fullness with the bimodal solution iii) Allergic reaction (although all patients have already been exposed to icodextrin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01242904
Study Brief:
Protocol Section:
NCT01242904