Status:
COMPLETED
Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
European Commission
Boehringer Ingelheim
Conditions:
Children
Chronic Renal Failure
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief Summary
In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin syste...
Detailed Description
Chronic kidney diseases affecting the nephron mass are characterized by a progressive decline of glomerular filtration rate (GFR) occurring irrespectively of the cause of the renal damage once a criti...
Eligibility Criteria
Inclusion
- Age 3-18 years
- Moderate state of renal failure (creatinine clearance 15 - 75 ml / min / 1.73 m²)
- Mean arterial blood pressure (ABPM) \> 50.percentile and/or antihypertensive treatment
- Written informed consent
Exclusion
- Age \<3 years or \>18 years at start of study
- Unstable clinical condition (vomiting, anorexia, etc) or superimposed important disease
- Unilateral or bilateral renal artery stenosis
- Urological surgery possibly affecting renal function expected during study period
- Insufficient compliance with prescribed antihypertensive medication during the run-in period
- Secondary renal diseases such as lupus, amyloidosis and primary hyperoxaluria, and patients treated with immunosuppressive agents (including corticosteroids)
- Severe primary cardiac disease, hepatic insufficiency and malabsorption syndrome
- Erythropoietin or growth hormone therapy with a duration of less than 3 months prior to run-in period
- Pregnancy
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00221845
Start Date
January 1 1998
End Date
January 1 2010
Last Update
January 12 2010
Active Locations (33)
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1
University Hospital Motol, 1st Department of Pediatrics
Prague, Czechia, 150 18
2
Hopital Necker, Division of Pediatric Nephrology
Paris, France, 75015
3
Inserm U574
Paris, France, 75015
4
Hopiteaux Universitaires de Strasbourg
Strasbourg, France, 67098