Chronic kidney disease is characterized by a progressive decline of glomerular filtration rate (GFR), which occurs irrespectively of the cause of the renal damage once a critical nephron mass has been lost.
Conditions
Interventions
Trade Name: Diovan 40 mg film-coated tablet
Product Name: Valsartan
Product Code: VAL489
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan
Current Sponsor code: VAL489
Concentrati
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (For Full list, see protocol) • Pediatric outpatients, 5-17 years of age, with a history of chronic kidney disease. • Male and female patients with body weight = 15 kg and = 100 kg are eligible. • Must be able to swallow tablets. • Must be receiving a standardized dose of an ACEI for at least for 2 months, for the treatment of proteinuria, without known ACEI-suspected adverse effects which could prevent the patient from continuing to receive the same dose of the ACEI for an additional 18 months. • Urine dipstick for protein = trace at Visit 1. • Proteinuria demonstrated in 2 of 3 early morning void urine specimen collections at Visit 2 (UPCR = 500 mg/g). • GFR = 30 ml/min/1.73m2 and = 90 ml/min/1.73m2, as estimated by the Schwartz formula using the Visit 1 serum creatinine value. • MSSBP/MSDBP must be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (For full list, see protocol): Renal transplant patients • Renal artery stenosis. • Patients with active systemic disease(s) (e.g. diabetes, amyloidosis, vasculitis, lupus nephritis) defined as those with current, recent (in the past two months) or frequent (= 2 episodes in the past 12 months) exacerbations of disease activity, and those in whom immunosuppressive medication was increased within two months prior to screening • Patients who are currently or within two months prior to screening on the following medications. [Note: Patients on maintenance immunosuppressive therapy (CsA, FK 506, MMF or azathioprine), administered at unchanged dose in the past 2 months pior to screening, and expected to remain unchanged throughout the study, are allowed.]: • Intraveous or oral cyclophosphamide • Intravenous or oral steroid pulse therapy • Oral steroid therapy >0.5 mg/kg/d • Serum potassium 5.3 mEq/L. • Hemoglobin < 8 gm/dL. • WBC < 3000/mm3. • Patients currently on Angiotensin II type-1 Receptor Blocker (ARB) therapy • Patients are not medically able or willing to discontinue aldosterone receptor antagonist and/or potassium sparing diuretic medications for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety and tolerability of valsartan versus placebo in children with Chronic Kidney Disease (CKD) manifested by persistent proteinuria (> 500 mg/g) while receiving a standardized dose of ACEI therapy to provide important prescribing information to the pediatrician on the use of valsartan in children with CKD.;Secondary Objective: • Evaluate the proportion of patients who have their UPCR reduced by = 50% from baseline to end of Period 1. • Evaluate the proportion of patients who have their urine albumin/creatinine ratio (UACR) reduced by = 50% from baseline to end of Period 1. • Evaluate proteinuria reduction as measured by UACR from baseline to end of Period 1 Entire study : To Evaluate: • Proportion of patients who have their UPCR reduced by = 50% from baseline to end of Period 2. • Proportion of patients who have their urine albumin/creatinine ratio (UACR) reduced by = 50% from baseline to end of Period 2. • Proteinuria reduction as measured by UPCR and UACR from baseline to end of Period 2. • Proportion of patients with = 25% GFR loss from baseline at end of Period 2. • Change in GFR (difference in slope) from baseline to end of treatment Period 2. • To evaluate the overall safety and tolerability of valsartan in this population.;Primary end point(s): Period 1 : Change from baseline in log (UPCR) month 4 Period 1 + Period 2 : Chronic slope of GFR over time, month 2 to 18 | — |
Countries
United Kingdom
Outcome results
None listed