Phase 3
Completed N=33
Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients
Hypertension Secondary to Kidney Transplant
Source: ClinicalTrials.gov NCT01007994 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants Who Are Non Dippers — 7; 12 Participants
◆ Published Evidence
Emerging
6citations · ~3 / year
Antihypertensive treatment for kidney transplant recipients.
Summary
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).
Linked Publications
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Antihypertensive treatment for kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Non Dippers |
7; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects age 5-21 years
- Stable kidney transplant recipients ( 30 ml/min/1.73 m2
- >6 months since kidney transplant
- ABPM: Non-dipper status defined as 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
Data sourced from ClinicalTrials.gov (NCT01007994) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.