Role of PACAP in Prothrombotic State and Tubular Response in Congenital and Infantile Nephrotic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01411982
First received: August 5, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  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. Additionally, some studies demonstrate its protective effect on the renal proximal tubule. 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. Next, PACAP deficiency in peritubular capillaries might have a negative effect on proximal tubular function and enhance progression of the interstitial renal damage.

To test our hypothesis, we will address three main key-objectives. First, the role of PACAP deficiency on pro-thrombotic state in patients with nephrotic syndrome will be studied using patient blood and urine samples. Secondly, the influence of PACAP on the kidney in health and in nephrotic syndrome will be examined, using human renal cell lines and human kidney material. Finally, we will study the role of PACAP on pro-thrombotic state and renal disease progression in vivo, using selected animal models of nephrotic syndrome.


Condition
Nephrotic Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Biospecimen Retention:   Samples Without DNA

Blood and urine


Estimated Enrollment: 35
Study Start Date: September 2011
  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

Contacts
Contact: Benedicte Eneman, Med. Doctor 0032-16-347285 benedicte.eneman@uzleuven.be
Contact: Elena Levtchenko, Med. Doctor 0032-16-343827 elena.levtchenko@uzleuven.be

Locations
Belgium
Pediatrics, UZ Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
  More Information

No publications provided

Responsible Party: Benedicte Eneman, UZ Leuven
ClinicalTrials.gov Identifier: NCT01411982     History of Changes
Other Study ID Numbers: S52866
Study First Received: August 5, 2011
Last Updated: August 5, 2011
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
Nephrosis
Kidney Diseases
Urologic Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014