Role of PACAP in Nehprotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:

Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411982
• Other study ID #: S52866
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: January 8, 2015
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
Belgium	Pediatrics, UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No