None listed
Conditions
Interventions
STRATUM OF HYPERTENSIVES Type of group
Transition Phase: This group will be composed of non-hypertensive patients from 1 to 17 years old. They will be treated with Losartan Placebo, in 25 or 50 mg tablets, PO, QD, for a total of 4 weeks.
Phase of Treatment to Double Blind: They will be divided in 2 possible treatments:
1) Losartan, in tablets of 25 or 50 mg, at a dose of 0.7 mg / kg up to 1.4 mg / kg, PO, QD, for a total of 12 weeks.
2) Losartan Placebo, in 25 or 50 mg tablets, PO, QD, for a total of 12 weeks.
Group name:
All patients who decide to enter the extension phase will be assigned to Losartan or Enalapril, in tablets, the dose will be adjusted at the investigator s discretion, PO, QD, for 2 years.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient is male or female and is between 1 and 17 years of age in the case of the non-hypertensive stratum or between 6 and 17 years of age in the case of the hypertensive stratum. b) The patient can provide a reliable sample of the first morning urine preferably obtained from a urination. c) The patient has a documented history of proteinuria associated with a chronic nephropathy of any etiology. d) The patient has a stable urine protein to creatinine ratio of ≥ 0.3 based on the average of three samples obtained during the baseline. e) The patient has a glomerular filtration rate ≥ 30 ml / min / 1.73m2. f) An informed consent by the parents is required. The patient´s consent will be obtained as required by local regulations.
Exclusion criteria
Exclusion criteria: a) The patient is pregnant or breastfeeding. b) The patient has a history of severe or symptomatic hypertension within a period of 1 year before Visit 1. c) The patient has a history of heart failure, hemodynamically significant obstructive valvular disease or cardiomyopathy. d) The patient has a clinically significant neurological, respiratory, gastrointestinal, hepatobiliary, or hematologic disease. e) The patient has a known history of coarctation of the uncorrected aorta, bilateral renal artery stenosis, or renal artery stenosis in a single kidney. f) The patient has a proteinuria of nephrotic range that responds to steroids. g) The patient has undergone a major organ transplant. h) The patient has clinically significant laboratory values ​​in Visit 1 outside the established normal range. i) The patient has a history of clinically significant rhythm disorders. j) The patient has received a therapy with an ACE inhibitor, a diuretic or an angiotensin II receptor antagonist (ARB) within 28 days prior to randomization. k) The patient has a known sensitivity to losartan or other ARB, enalapril or other ACEI, or a history of angioneurotic edema. l) The patient has a known sensitivity to amlodipine or another calcium channel blocker. m) The patient requires ciclosporin or tacrolimus to treat their nephropathy. n) The patient who will not cooperate fully, will not keep his appointments, or who has been generally unreliable. o) The patient has any other factor that limits their participation. p) The patient is currently participating or has participated in a study with a compound under investigation within 30 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Sample of first morning urine, for the measurement of the ratio of protein to creatinine in urine and determination of GFR. The final value will be defined as the average of the measurements taken in the previous 3 consecutive days. Measure:Changes in urinary protein excretion. Timepoints:At 12 weeks. ; Outcome name:Sample of first morning urine, for the measurement of the ratio of protein to creatinine in urine and determination of GFR. Measure:Changes in urinary protein excretion and GFR during the extension phase. Timepoints:At 2 years (extension phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Complete physical examination (Does not include breasts, urogenital region or rectal). Criterion 2: The pulse rate, blood pressure and weight will be measured. Blood pressure will be measured in the sitting position. Criterion 3: Panels of hematology and serum chemistry. Criterion 4: Clinical evaluation of any unfavorable and involuntary change in the structure, function or biochemistry of the body, temporarily associated with the use of the product under investigation. Criterion 5: Stadiometer, which is a measurement recording instrument that provides readings in a range of 600 mm (60 cm) to 2100 mm (210 cm). Criterion 6: Clinical evaluation of Turner s sexual development stages. Measure:Security: 1) Physical examination. 2) Vital signs. 3) Laboratory. 4) Adverse events. 5) Growth. 6) Sexual development. Timepoints:Criteria 1, 5 and 6: Weeks -2 and 12. Criterion 2: Weeks -4, -2 and -1, day 1 and weeks 1, 2, 4, 6, 8, 10 and 12. Criterion 3: Week -4, day 1 and weeks 2 and 12. Criterion 4: Weeks -2 and -1, day 1 and weeks 1, 2, 4, 6, 8, 10 and 12. ; Outcome name:Sample of first morning urine, for the measurement of the ratio of protein to creatinine in urine and determination of GFR. The final value will be defined as the average of the measurements taken in 3 consecutive days. Measure:1) Change in urinary protein excretion in the extension phase. 2) Change in the GFR in the extension phase. Timepoints:At 2 years of extension. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed