Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients

Completed · Phase 2/Phase 3

Conditions studied: Hypertension Secondary to Kidney Transplant

In brief

The proposed study investigated the effect of chronotherapeutic alteration of anti-hypertensive medication on nocturnal hypertension and end-organ injury in pediatric renal transplant recipients who are non-dippers. Additionally, the investigators examined the association between response to intervention, serum adiponectin levels and adiponectin gene polymorphisms. The investigators hypothesized that (1) evening administration of anti-hypertensive medication will convert subjects from non-dipper to dipper status, improve mean nocturnal blood pressure (BP), and improve nocturnal BP load, (2) evening administration of anti-hypertensive medication will reduce albuminuria, left ventricular mass index (LVMI), rate of decline of glomerular filtration rate (eGFR) and will decrease pulse wave velocity (PWV).

Key facts

Study ID

NCT01007994

Run by

Northwell Health

People needed

33

Starts

2009-11-01

Expected to finish

2020-08-01

Last updated by the study team

2021-04-13

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.