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

Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension Secondary to Kidney Transplant

Intervention: New Medication: Enalapril, Isradipine, Propranolol (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: North Shore Long Island Jewish Health System

Official(s) and/or principal investigator(s):
Christine B Sethna, MD, EdM, Principal Investigator, Affiliation: North Shore Long Island Jewish Health System

Overall contact:
Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu

Summary

The proposed study will investigate 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 aim to examine the association between response to intervention, serum adiponectin levels and adiponectin gene polymorphisms. The investigators hypothesize 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), and (3) lower adiponectin levels and presence of adiponectin gene polymorphisms will be associated with less of a response to the intervention.

Clinical Details

Official title: Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Proportion of subjects in each of the treatment arms who change from non-dipper to dipper status

Secondary outcome:

Change in night-time systolic/diastolic blood pressure

Change in left ventricular mass index

Change in albumin:creatinine ratio

Change in estimated glomerular filtration rate

Change in pulse wave velocity

Association of serum adiponectin levels and SNPs of adiponectin with outcomes

Eligibility

Minimum age: 5 Years. Maximum age: 21 Years. Gender(s): Both.

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

Locations and Contacts

Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu

Cohen Children's Medical Center of NY, New Hyde Park, New York 11040, United States; Recruiting
Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu
Christine B Sethna, MD, EdM, Principal Investigator
Howard Trachtman, MD, Sub-Investigator

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Kevin EC Meyers, MbbCh, Phone: 215-590-2449, Email: meyersk@email.chop.edu
Kevin EC Meyers, MbbCh, Principal Investigator
Cathy Laney, CRNP, Sub-Investigator

Additional Information

Starting date: November 2009
Last updated: April 20, 2015

Page last updated: August 23, 2015

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