Randomized controlled trial of the Effectiveness of Drug Usage : Ca channel blocker for Early stage hypertension in idiopathic nephrotic syndrome

Phase 2

Recruiting

• Conditions: nephrotic syndrome; proteinuria, hypoproteinemia, edema

• Registration Number: JPRN-jRCTs031180396
• Lead Sponsor: Harada Ryoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Patients diagnosed as initial idiopathic nephrotic syndrome
(1) Urine protein creatinine ratio > 2.0 g/gCr
(2) Serum albumin level < 2.5 g/dL
2) Patients treated by ISKDC( International study of kidney disease in children) regimen
3) Aged 1 years or older and younger than 16 years at the time of consent
4) written informed consent by legal guardian
5) Systemic blood pressure levels over 95th percentile to under 95th percentile + 12 mmHg, or 130/80 to 139/89 mmHg (whichever is lower) are lasted 2days

Exclusion Criteria

1) Nephritic nephrotic syndrome such as IgA nephropathy
2) Patients with the following disease : vascular purpura, systemic lupus erythematosus, secondary nephrotic syndrome)
3) Taking antihypertensive drugs not including diuretics
4) Diagnosed with S2 hypertension
5) Height exceeds beyond 2 SD from gender / age reference value
6) History of hypersensitivity to amlodipine
7) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of cases who had no event of antihypertensive treatment and who was less than S1 hypertension at day 28

Secondary Outcome Measures

Name	Time	Method
(1) Time to event<br>Duration until events occurrence date of 1 and 2 below, and the frequency of events below<br> 1 less than S1 hypertension<br> 2 above S2 hypertension<br>(2) Time to treatment failure<br>Duration until the earliest occurrence of event below<br>1 Changing treatment is necessary due to insufficient efficacy of study treatment<br>2 Difficult continuation of study treatment<br>3 Offer to stop examination treatment from examinee or legal guardian<br>(3) The difference between the blood pressure at the time of allocation and the blood pressure at the evaluation day<br>(4) Amlodipine dose at the time of secondary endpoint<br>(5) Duration from S1 hypertension to less than S1<br>(6) Frequency of PRES (Posterior reversible encephalopathy syndrome: reversible occipital white matter encephalopathy) <br>(7) Frequency of occurrence about adverse event of amlodipine between 1 year old and 6 years old<br>(8) Adverse events during study treatment