EUCTR2006-001812-65-GB
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled, parallelgroup, multicenter study to evaluate the effect of valsartanon proteinuria and glomerular filtration rate in children withChronic Kidney Disease who are receiving a standardizeddose of angiotensin converting enzyme inhibitor therapy
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 \< 95th percentile, for age, gender and height, at Visit 2, by office blood pressure measurement.
- •Are the trial subjects under 18? yes
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 \< 3\.5 or \> 5\.3 mEq/L.
- •Hemoglobin \< 8 gm/dL.
Investigators
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