Role of PACAP in Nehprotic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Dr Benedicte Eneman, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01411982
First received: August 5, 2011
Last updated: January 8, 2015
Last verified: January 2015

August 5, 2011
January 8, 2015
September 2011
September 2014   (final data collection date for primary outcome measure)
PACAP levels in plasma and urine [ Time Frame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01411982 on ClinicalTrials.gov Archive Site
  • Platelet count [ Time Frame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months ] [ Designated as safety issue: No ]
  • Platelet aggregability [ Time Frame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months ] [ Designated as safety issue: No ]
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Role of PACAP in Nehprotic Syndrome
Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome

This study will identify the role of PACAP (pituitary adenylate cyclase-activating polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and causes blood platelet activation, which contribute to the increased rate of thromboembolic disease in these patients.

To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with nephrotic syndrome will be studied using patient blood and urine samples.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood and urine

Non-Probability Sample

New patients with nephrotic syndrome of patients during a relapse of nephrotic syndrome.

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
29
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • New patient with nephrotic syndrome of patient during relapse of nephrotic syndrome
  • Under 16 years old
  • Treatment for nephrotic syndrome not yet started by first sample collection

Exclusion Criteria:

  • None
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01411982
S52866
No
Dr Benedicte Eneman, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Not Provided
Universitaire Ziekenhuizen Leuven
January 2015

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