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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01007994
Eligibility Criteria:
Inclusion Criteria:
* Subjects age 5-21 years
* Stable kidney transplant recipients (\<30% change in eGFR in past 3 months)
* eGFR \> 30 ml/min/1.73 m2
* \>6 months since kidney transplant
* ABPM: Non-dipper status defined as \<10% decline in systolic or diastolic blood pressure from daytime to night-time
Exclusion Criteria:
* ABPM: Subjects with daytime mean blood pressure \> 95% for height and sex
* Subjects on diuretic monotherapy will not be eligible for the time change group (to avoid discomfort of nocturnal enuresis)
* Subjects with nephrotic range proteinuria
* Subjects with major co-morbid conditions such as cardiac disease, pulmonary disease and diabetes mellitus
* Subjects/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
* Subjects who are pregnant will not be eligible for the new medication group
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT01007994
Study Brief:
Protocol Section:
NCT01007994