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

NCT00221845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2010-01-12

No results posted yet for this study

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.

Conditions

  • Children
  • Chronic Renal Failure
  • Hypertension
  • Acquired Kidney Disease
  • Congenital Kidney Disease

Interventions

DRUG

ACE Inhibition

ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.

DRUG

Intensified Blood Pressure Control

Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.

DRUG

Add-on Angiotensin Receptor Blockade

In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Franz Schaefer, MD · University of Heidelberg, Children's Hospital

  • Otto Mehls, MD · University of Heidelberg, Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2007-07-31
Completion
2010-01-31

Countries

  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Serbia
  • Sweden
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221845 on ClinicalTrials.gov