Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in Children in the Conservative Phase of Chronic Kidney Disease: A Randomized Controlled Trial

Not Applicable

• Conditions: Children in the Conservative Phase of Chronic Kidney Disease

• Registration Number: JPRN-UMIN000006917
• Lead Sponsor: Japanese pediatric CKD study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-20
• Study Completion: 2023-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

(1)The patient has a history of renal transplant. (2)The patient receives dialysis therapy at registration or needs to undergo dialysis therapy promptly. (3)The patient has a serious impaired liver function (GOT or GPT higher than 2.5 times of the upper limit of the reference value) at registration. (4)White cell count is less than 3000/mm3 or platelet count is less than 100,000/mm3 at registration. (5)Serum potassium level exceeds the upper limit of the reference value at registration despite appropriate treatment. (6)A patient with bilateral renal artery stenosis or patient having only one kidney with renal artery stenosis. (7)The patient has a passage disorder to the alimentary canal. (8)The patient has poorly controlled hypertension at registration. More than 99 percentile in the blood pressure reference value list according to the sex and age of children. (9)Patient with a previous history of hypersensitivity to an ingredient of Valsartan or other ARB or the spherical carbon adsorbent. (10)ACEI, ARB or the spherical carbon adsorbent was given within 14 days before registration. (11) The patient is participating in other clinical study or trial at registration. (12)A woman who is pregnant or of childbearing potential or who is nursing. (13)A woman who wishes to become pregnant during the study period. (14)In addition, patients who are judged to be inappropriate for study subjects by the doctor in attendance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The period until the date of the earliest development of any event among four events, including the following events, (1)-(3), and death due to any cause, with the date of registration as the initial date of reckoning: (1)Elevation 1.5 times or higher than the base-line value of serum creatinine concentration (2)Dialysis introduction (3)Performance of renal transplant