IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorSun Yat-sen University
About this trial
This prospective cohort study is designed to examine the association between blood and urine biomarkers (including genetic variants) and long-term kidney disease progression among 2000 Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female individuals aged 14 years or older
Patients with biopsy-proven primary IgA nephropathy
A renal biopsy available for reviewing must include 10 or more glomeruli.
The first renal biopsy was performed within 3 years.
Disqualifiers
Relatives were diagnosed with biopsy-proven primary IgA nephropathy;
Individuals had secondary IgA nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.
Trial population
Patients with biopsy-proven primary IgA nephropathy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: IgA nephropathy group1 intervention
Trial outcomes
Primary outcomes
1
A doubling of serum creatinine level from baseline
Time frame
120 months2
Progression to end stage renal disease (eGFR<15ml/min/1.73 m2, dialysis or transplantation）
Time frame
120 months3
Death
Time frame
120 monthsSecondary outcomes
1
Remission of proteinuria (complete or partial)
Time frame
120 monthsSponsors and contacts
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Source ClinicalTrials.gov