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
  Purpose

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.


Condition
Nephrotic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Blood and urine


Enrollment: 29
Study Start Date: September 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01411982

Locations
Belgium
Pediatrics, UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
  More Information

No publications provided

Responsible Party: Dr Benedicte Eneman, Doctor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01411982     History of Changes
Other Study ID Numbers: S52866
Study First Received: August 5, 2011
Last Updated: January 8, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
PACAP (pituitary adenylate cyclase-activating polypeptide)
Nephrotic syndrome
Thrombosis
Platelets

Additional relevant MeSH terms:
Nephrotic Syndrome
Syndrome
Disease
Kidney Diseases
Nephrosis
Pathologic Processes
Urologic Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Cardiovascular Agents
Growth Substances
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on July 01, 2015