Children in the Conservative Phase of Chronic Kidney Disease
Conditions
Interventions
It starts with Valsartan at a dose of 0.5 mg/kg/day (maximal dose 40 mg/day). It is to be given by oral administration once a day (after breakfast), and the percent tablet can be crushed or bisected.
Sponsors
Japanese pediatric CKD study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patient age at the registration is 1-19 years. (2)The patient falls under CKD stage 3 or 4 in the pediatric CKD stage judgment list. (3)The patient is able to go to hospital through the study treatment period. (4)Writen consent to participation in this study has been obtained from the patient's legal guardian.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Time to treatment failure The period until the date of the earliest development of any event among eight events, including the following events, 1 - 4, in addition to main endpoint events, 1 - 3, and death due to any cause, with the date of registration as the initial date of reckoning: If it can be confirmed by observation twice in a row that the rate of test drug compliance during the study period is less than 50% (excluding drug discontinuation and drug withdrawal due to adverse events or according to a doctor's direction). Drug compliance shall be judged based on the mean amount of the drug taken during a week on the basis of the patient's clinical diary. If the less than 50% test drug compliance rate during the study period can be confirmed by observation twice in a row, the date of the first confirmation of the less than 50% compliance rate shall be the date of event onset. If the doctor in attendance judges that treatment with the test drug needs to be changed because the effect of the test drug is inadequate. If the doctor in attendance judges that it is difficult to continue the treatment with the test drug due to the onset of an adverse event, etc. If the patient or the patient's legal guardian offers discontinuation of the test drug therapy. (In the case of falling under any of the above reasons 1) to 3), reason 4) shall not be applicable.) (2) Time to the day of dialysis introduction or that of kidney transplantation (3) Estimated glomerular filtration rate (4) Reciprocal inclination of serum creatinine level (5) Urinary protein to creatinine ratio (6) Rate of CKD stage migration (7) Adverse events during the treatment with the test drug | — |
Countries
Japan
Contacts
Public ContactYuko Hamasaki
Toho University Faculty of Medicine Department of Pediatric Nephrology
Outcome results
None listed