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

Japanese pediatric CKD study group0 个研究点目标入组 120 人开始时间: 2011年12月20日最近更新: 2023年10月17日

适应症

试验速览

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•(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.

发起方

Japanese pediatric CKD study group