ESCAPE Trial - Full Text View - ClinicalTrials.gov

Sponsor:	University of Heidelberg
Collaborators:	European Commission Boehringer Ingelheim Pharmaceuticals Baxter Extramural Grant Aventis Pharmaceuticals
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00221845

Purpose

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	Intervention	Phase
Children Chronic Renal Failure Hypertension Aquired Kidney Disease Congenital Kidney Disease	Drug: ramipril Procedure: intensified blood pressure control	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Kidney Failure

Drug Information available for: Ramipril

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Change in creatinine clearance (regression line slope of an individual’s creatinine clearance)
Time interval to renal ‘loss’ as defined by an absolute decrease in creatinine clearance by 50 %.

Secondary Outcome Measures:

Effect of treatment on urinary protein excretion
Effect of treatment on blood pressure
Safety of treatment

Estimated Enrollment:	400
Study Start Date:	January 1998
Estimated Study Completion Date:	September 2005

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Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221845

Show 33 Study Locations

Sponsors and Collaborators

University of Heidelberg

European Commission

Boehringer Ingelheim Pharmaceuticals

Baxter Extramural Grant

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Wuhl E, Mehls O, Schaefer F; ESCAPE Trial Group. Antihypertensive and antiproteinuric efficacy of ramipril in children with chronic renal failure. Kidney Int. 2004 Aug;66(2):768-76.

Jourdan C, Wuhl E, Litwin M, Fahr K, Trelewicz J, Jobs K, Schenk JP, Grenda R, Mehls O, Troger J, Schaefer F. Normative values for intima-media thickness and distensibility of large arteries in healthy adolescents. J Hypertens. 2005 Sep;23(9):1707-1715.

Litwin M, Wuhl E, Jourdan C, Trelewicz J, Niemirska A, Fahr K, Jobs K, Grenda R, Wawer ZT, Rajszys P, Troger J, Mehls O, Schaefer F. Altered morphologic properties of large arteries in children with chronic renal failure and after renal transplantation. J Am Soc Nephrol. 2005 May;16(5):1494-500. Epub 2005 Mar 16.

Wuhl E, Hadtstein C, Mehls O, Schaefer F. Ultradian but not circadian blood pressure rhythms correlate with renal dysfunction in children with chronic renal failure. J Am Soc Nephrol. 2005 Mar;16(3):746-54. Epub 2005 Jan 12.

Hadtstein C, Wuhl E, Soergel M, Witte K, Schaefer F. Normative values for circadian and ultradian cardiovascular rhythms in childhood. Hypertension. 2004 Mar;43(3):547-54. Epub 2004 Jan 26.

Wuhl E, Hadtstein C, Mehls O, Schaefer F; Escape Trial Group. Home, clinic, and ambulatory blood pressure monitoring in children with chronic renal failure. Pediatr Res. 2004 Mar;55(3):492-7. Epub 2003 Nov 19.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

ESCAPE Trial Group; Wühl E, Trivelli A, Picca S, Litwin M, Peco-Antic A, Zurowska A, Testa S, Jankauskiene A, Emre S, Caldas-Afonso A, Anarat A, Niaudet P, Mir S, Bakkaloglu A, Enke B, Montini G, Wingen AM, Sallay P, Jeck N, Berg U, Caliskan S, Wygoda S, Hohbach-Hohenfellner K, Dusek J, Urasinski T, Arbeiter K, Neuhaus T, Gellermann J, Drozdz D, Fischbach M, Möller K, Wigger M, Peruzzi L, Mehls O, Schaefer F. Strict blood-pressure control and progression of renal failure in children. N Engl J Med. 2009 Oct 22;361(17):1639-50.

Study ID Numbers:	QLRT-2001-00908
Study First Received:	September 15, 2005
Last Updated:	September 15, 2005
ClinicalTrials.gov Identifier:	NCT00221845 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

Ramipril
Hypertension
Chronic renal failure
Disease progression
Left ventricular hypertrophy

Intima media thickness
Cardiovascular disease
Biomarkers
Gene polymorphisms

Additional relevant MeSH terms:

Renal Insufficiency
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Kidney Failure, Chronic
Disease Progression
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril

Protease Inhibitors
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Kidney Diseases
Hypertension
Kidney Failure

ClinicalTrials.gov processed this record on November 20, 2009