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
  Purpose

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
Nephrotic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fluid Balance, Hormones and Urine Proteomics in Nephrotic Syndrome in Childhood

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Biospecimen Retention:   Samples With DNA

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


Enrollment: 21
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690586

Locations
Denmark
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
Investigators
Study Director: Søren Rittig, MD Aarhus University Hospital Skejby
  More Information

No publications provided

Responsible Party: Rene Frydensbjerg Andersen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00690586     History of Changes
Other Study ID Numbers: nsdk07-09
Study First Received: June 2, 2008
Last Updated: June 7, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on July 23, 2014