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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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27 July 2020 |
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Main ID: |
EUCTR2006-001812-65-GB |
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Date of registration:
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01/08/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized, double-blind, placebo-controlled, parallel
group, multicenter study to evaluate the effect of valsartan
on proteinuria and glomerular filtration rate in children with
Chronic Kidney Disease who are receiving a standardized
dose of angiotensin converting enzyme inhibitor therapy
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Scientific title:
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A randomized, double-blind, placebo-controlled, parallel
group, multicenter study to evaluate the effect of valsartan
on proteinuria and glomerular filtration rate in children with
Chronic Kidney Disease who are receiving a standardized
dose of angiotensin converting enzyme inhibitor therapy |
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Date of first enrolment:
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18/08/2006 |
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Target sample size:
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314 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001812-65 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
• 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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.
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Intervention(s)
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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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Diovan 80 mg film-coated tablet
Product Name: Valsartan
Product Code: VAL489
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan
Current Sponsor code: VAL 489
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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.
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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.
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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
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Secondary ID(s)
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Not applicable
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CVAL489K2301
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 18/08/2006
Contact:
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