ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221845
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2010
Sponsor:
Collaborators:
European Commission
Boehringer Ingelheim
Baxter Healthcare Corporation
Aventis Pharmaceuticals
Information provided by:
Heidelberg University

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 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.

Condition or disease Intervention/treatment Phase
Children Chronic Renal Failure Hypertension Acquired Kidney Disease Congenital Kidney Disease Drug: ACE Inhibition Drug: Intensified Blood Pressure Control Drug: Add-on Angiotensin Receptor Blockade Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure
Study Start Date : January 1998
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Active Comparator: Conventional BP Control
Targeted 24-hour mean arterial pressure will be the 50th-95th percentile for age.
Drug: ACE Inhibition
ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
Other Name: Delix

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.
Other Name: Micardis

Experimental: Intensified BP Control
Targeted 24-hour mean arterial pressure will be the 5th to 50th percentile for age.
Drug: ACE Inhibition
ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
Other Name: Delix

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.
Other Name: Micardis




Primary Outcome Measures :
  1. Time interval to renal 'loss' as defined by an absolute decrease in creatinine clearance by 50 % or attainment of renal replacement therapy. [ Time Frame: two-monthly ]

Secondary Outcome Measures :
  1. Effect of treatment on urinary protein excretion [ Time Frame: two-monthly ]
  2. Effect of treatment on blood pressure [ Time Frame: two-monthly ]
  3. Safety of treatment [ Time Frame: initially weekly, than two-monthly ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221845


  Show 33 Study Locations
Sponsors and Collaborators
Heidelberg University
European Commission
Boehringer Ingelheim
Baxter Healthcare Corporation
Aventis Pharmaceuticals
Investigators
Principal Investigator: Franz Schaefer, MD University of Heidelberg, Children's Hospital
Principal Investigator: Otto Mehls, MD University of Heidelberg, Children's Hospital

Publications of Results:
Other Publications:

Responsible Party: Prof. Dr. med. Dr. hc. Franz Schaefer, University Hospital for Pediatric and Adolescent Medicine
ClinicalTrials.gov Identifier: NCT00221845     History of Changes
Other Study ID Numbers: QLRT-2001-00908
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by Heidelberg University:
Ramipril
Hypertension
Chronic renal failure
Disease progression
Left ventricular hypertrophy
Intima media thickness
Cardiovascular disease
Biomarkers
Gene polymorphisms

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Disease Progression
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes