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Role of PACAP in Nehprotic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411982
First Posted: August 8, 2011
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Dr Benedicte Eneman, Universitaire Ziekenhuizen Leuven
  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

Resource links provided by NLM:


Further study details as provided by Dr Benedicte Eneman, 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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Benedicte Eneman, Doctor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01411982     History of Changes
Other Study ID Numbers: S52866
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: January 9, 2015
Last Verified: January 2015

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

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


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