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Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood

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ClinicalTrials.gov Identifier: NCT00690586
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 8, 2010
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to describe the hormones controlling fluid balance in pediatric patients with nephrotic syndrome. Further more, an analysis of the urinary and plasma proteins will be done using proteomics. Different composition of proteins in the urine or plasma might indicate if the patients will respond to treatment or not.

Condition or disease
Nephrotic Syndrome

Detailed Description:

Nephrotic syndrome represents the association of proteinuria, hypoalbuminemia, oedema and hyperlipidemia. The pathogenesis of the oedemas remains controversial. The "underfill" theory is the traditional explanation where massive proteinuria leads to low plasma albumine and a subsequent decrease in intravascular osmotic pressure leading to edema formations. Because most patients are normotensive and have normal intravascular pressure the "overfill" theory has been proposed suggesting a primary defect in renal sodium handling being responsible for oedema formation.

Ten percent of the children with nephrotic syndrome do not respond to standard steroid treatment and a significant proportion of these patients progress towards end-stage renal failure. At initial presentation it cannot be said if a patient will respond to treatment or not.

The purposes of the sudy:

  1. To describe changes in the hormones, Aldosterone, Atrial Natriuretic Peptide (ANP), Arginin Vasopressin (AVP), Renin and Angiotensin II in patients with idiopathic nephrotic syndrome and to analyse to what extend the change in these hormones reflected a "underfill" or "overfill" situation.
  2. To describe changes in the urine concentration of the water channel AQP II and the sodium channel ENaC during the course of nephrotic syndrome.
  3. To test the hypothesis that urine and plasma proteomics from patients with steroid resistant nephrotic syndrome differs from patients with steroid sensitive nephrotic syndrome.

50 pediatric patients with nephrotic syndrome will be included after informed consent from both parents.

At day 1, 2, 3, 30 and 120 blood samples for hormones will be taken together with creatinin, albumine, Na+, K+, Hgb. An Echocardiography will be performed at day 1 and day 30 to determine v. cava inferior index.

At day 1,30 and 120 urine and plasma will be collected for proteomics and measurement of AQP II and ENaC concentrations.

Further more a clinical examination will be performed at day 1, 2, 3, 30 and 120 and weight, blood pressure and response to treatment will be recorded.

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Study Start Date : December 2007
Primary Completion Date : May 2010
Study Completion Date : May 2010

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U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood samples for hormone analyzes Urine samples for urine protomis, AQP II and ENaC

Eligibility Criteria

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with nephrotic syndrome will be included from 5 pediatric centrs in Denmark.

Inclusion Criteria:

  • Idiopathic Nephrotic syndrome, age below 15 years

Exclusion Criteria:

  • Systemic disease e.g. Henoch-Schonleins purpura, Lupus erythematosus, diabetes mellitus
  • Age over 15 years
  • Treatment with diuretics prior to baseline blood samples
Contacts and Locations

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): NCT00690586

Department of Pediatrics, Aarhus University Hospital, Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
The Danish Medical Research Council
The Danish Kidney Association
Study Director: Søren Rittig, MD Aarhus University Hospital Skejby
More Information

Responsible Party: Rene Frydensbjerg Andersen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00690586     History of Changes
Other Study ID Numbers: nsdk07-09
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2008

Keywords provided by Aarhus University Hospital:
Nephrotic syndrome
Underfill and overfill theory
Steroid resistance
Urine proteomics
Angiotensin II
Renin and Aldosterone

Additional relevant MeSH terms:
Nephrotic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs