The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKolding Sygehus
About this trial
Nephrotic syndrome (NS) is characterized by gross proteinuria (\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality.
The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses:
1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls 2. The level of PCSK9 in plasma correlates to the degree of proteinuria. 3. PCSK9 i increased in the kidney tissue of patients with NS
The study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old
Patients admitted to the Medical Department and/or the Medical Emergency Department, Kolding Sygehus.
Disqualifiers
Refusal to give informed consent
Treatment with PCSK9 inhibitors
Any acute or chronic condition that would limit the ability of the patient to participate in the study
Control group: proteinuria
Trial population
Patient with \>3.5 g/day of proteinuria will be included in the nephrotic syndrome group. Control test subjects will be excluded if proteinuria occur.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 3 trial groupsGroup A: Nephrotic syndrome
Group B: Kidney healthy controls
Group C: Kidney biopsy control
Trial outcomes
Primary outcomes
1
Plasma PCSK9 correlated to the degree of protein in the urine
PCSK9 in plasma measured by ELISA, correlated to protein in 24hour urine
Time frame
Measured at inclusion and for the nephrotic group after remission, if this is accomplished within a year2
Degree of PCSK9 in kidney tissue
Immunohistochemistry; degree of staining a in test persons, who are subjected to kidney biopsy.
Time frame
Measured at inclusion in test person group, if this is performed within in the study period (before august 2028).Secondary outcomes
1
Localization of PCSK9 in kidney tissue
Immunohistochemistry; localization of staining a in test persons, who are subjected to kidney biopsy.
Time frame
Measured at inclusion in test person group, if this is performed within in the study period (before august 2028).Sponsors and contacts
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Source ClinicalTrials.gov