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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007994
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : February 3, 2017
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Christine B Sethna, MD, Northwell Health

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Secondary to Kidney Transplant Drug: New Medication: Enalapril, Isradipine, Propranolol Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients
Study Start Date : November 2009
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: New Medication
A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.
Drug: New Medication: Enalapril, Isradipine, Propranolol

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

Other Name: Vasotec, DynaCirc, Inderal
No Intervention: Control
Subjects in the control group will continue to take their medications as usual.

Primary Outcome Measures :
  1. Proportion of subjects in each of the treatment arms who change from non-dipper to dipper status [ Time Frame: 3 months and 6 months ]

Secondary Outcome Measures :
  1. Change in night-time systolic/diastolic blood pressure [ Time Frame: 3 months and 6 months ]
  2. Change in left ventricular mass index [ Time Frame: 3 months and 6 months ]
  3. Change in albumin:creatinine ratio [ Time Frame: 3 months and 6 months ]
  4. Change in estimated glomerular filtration rate [ Time Frame: 3 months and 6 months ]
  5. Change in pulse wave velocity [ Time Frame: 3 months and 6 months ]
  6. Association of serum adiponectin levels and SNPs of adiponectin with outcomes [ Time Frame: 3 months and 6 months ]

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007994

United States, New York
Cohen Children's Medical Center of NY
New Hyde Park, New York, United States, 11040
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Northwell Health
Children's Hospital of Philadelphia
Principal Investigator: Christine B Sethna, MD, EdM Northwell Health

Responsible Party: Christine B Sethna, MD, Division Director, Pediatric Nephrology, Northwell Health Identifier: NCT01007994     History of Changes
Other Study ID Numbers: 09-054
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Christine B Sethna, MD, Northwell Health:
Nocturnal hypertension
Renal Transplant
Pulse Wave Velocity
Pediatric Renal Transplant Recipient

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators