CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
New Medication: Enalapril, Isradipine, Propranololdrug
Likely dose
New Medication: Enalapril, Isradipine, Propranolol 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01007994
NCT01007994Phase 3Completed

Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients

Northwell Health·interventional·Posted Nov 5, 2009·Updated Apr 13, 2021

In Brief

A Phase 3 clinical trial evaluating New Medication: Enalapril, Isradipine, Propranolol for Hypertension Secondary to Kidney Transplant. Completed, enrolled 33 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2009
Enrollment StartNov 1, 2009
Primary CompletionJan 1, 2020
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 16.7 years ago

Interventions

New Medication: Enalapril, Isradipine, Propranololdrug

Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added. Dosing will be as follows: ACEI: Enalapril \< 40 kg starting dose 2.5 mg titrate to 5 mg \> 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine \< 40 kg 2.5 mg \> 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol \<40 kg starting dose 10 mg titrate to 20 mg \>40 kg starting dose 20 mg titrate to 40 mg