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

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
The Danish Kidney Association
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00690586
First received: June 2, 2008
Last updated: June 7, 2010
Last verified: June 2008

June 2, 2008
June 7, 2010
December 2007
May 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00690586 on ClinicalTrials.gov Archive Site
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Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood
Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood samples for hormone analyzes Urine samples for urine protomis, AQP II and ENaC

Probability Sample

Patients with nephrotic syndrome will be included from 5 pediatric centrs in Denmark.

Nephrotic Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00690586
nsdk07-09
No
Rene Frydensbjerg Andersen, Aarhus University Hospital
Aarhus University Hospital
  • The Danish Medical Research Council
  • The Danish Kidney Association
Study Director: Søren Rittig, MD Aarhus University Hospital Skejby
Aarhus University Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP