Role of PACAP in Nehprotic Syndrome
Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome
1 other identifier
observational
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJanuary 9, 2015
January 1, 2015
3 years
August 5, 2011
January 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PACAP levels in plasma and urine
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
Secondary Outcomes (2)
Platelet count
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
Platelet aggregability
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
Eligibility Criteria
New patients with nephrotic syndrome of patients during a relapse of nephrotic syndrome.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatrics, UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Biospecimen
Blood and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 8, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
January 9, 2015
Record last verified: 2015-01