Trial Outcomes & Findings for Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients (NCT NCT01007994)

NCT ID: NCT01007994

Last Updated: 2021-04-13

Results Overview

Percentage of subjects in each of the treatment arms who are nondippers, defined as systolic or diastolic nocturnal dip \<10%

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 33 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-04-13

Participant Flow

Participant milestones

Measure	New Medication A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm. 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	Control Subjects in the control group will continue to take their medications as usual.
Overall Study STARTED	17	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	New Medication n=17 Participants A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm. 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	Control n=16 Participants Subjects in the control group will continue to take their medications as usual.	Total n=33 Participants Total of all reporting groups
Age, Continuous	10.9 years STANDARD_DEVIATION 4.3 • n=5 Participants	14.3 years STANDARD_DEVIATION 4.2 • n=7 Participants	12.6 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Black	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Left Ventricular Mass Index	49.1 g/m^2.7 STANDARD_DEVIATION 14.1 • n=5 Participants	39.7 g/m^2.7 STANDARD_DEVIATION 12.3 • n=7 Participants	44.4 g/m^2.7 STANDARD_DEVIATION 13.2 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Percentage of subjects in each of the treatment arms who are nondippers, defined as systolic or diastolic nocturnal dip <10%

Outcome measures

Measure	New Medication n=17 Participants A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm. 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	Control n=16 Participants Subjects in the control group will continue to take their medications as usual.
Number of Participants Who Are Non Dippers	7 Participants	12 Participants

Adverse Events

New Medication

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	New Medication n=17 participants at risk A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm. 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	Control n=16 participants at risk Subjects in the control group will continue to take their medications as usual.
Renal and urinary disorders Hyperkalemia	5.9% 1/17 • Number of events 1 • 30 days after treatment duration of 6 months	0.00% 0/16 • 30 days after treatment duration of 6 months

Additional Information

Christine Sethna

Northwell

Phone: 7184703423

Email: csethna@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place