Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Aventis Pharmaceuticals; Baxter Healthcare Corporation; Boehringer Ingelheim; European Commission
• Treatments: Telmisartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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