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NCT Number: NCT02954419

IgA Nephropathy Biomarkers Evaluation Study (INTEREST)

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).

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Xue Qing Yu, M.D.& Ph.D.

CONTACT

[email protected]

8620-87766335

About this study

Glomerulonephritis is the leading cause of end-stage renal disease (ESRD) in China, where IgA nephropathy (IgAN) is the most common primary glomerulonephritis among individuals undergoing renal biopsy. The outcomes of IgAN vary highly among individuals; some have the stable renal function for lifetime and some quickly progress to ESRD. No biomarker is widely applied to predict the outcomes in IgAN yet. Previous GWAS studies including ours have identified some susceptibility loci associated with the development and clinical features of IgAN. In addition, a few cohort studies have revealed several genetic loci related to the progression of IgAN. But, all of the reported GWAS studies were based on a case-control design, which may not provide the information about the effect of genetic variants on the progression of disease. Previous cohort studies which focused on certain specific candidate genes cannot unbiasedly explore the progression related susceptibility loci. Furthermore, there is no study that integrates the information from whole genomic loci and serum and urine biomarkers to predict the long-term progression in IgAN. Therefore, we design a relative large prospective cohort study to examine the association between blood and urine biomarkers (including whole genomic loci) and long-term kidney disease progression among 2000 Chinese IgAN patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • eGFR ≥ 60 ml/min/1.73 m2 (MDRD formula);
  • Individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF).

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. A doubling of serum creatinine level from baseline

    Time frame: 120 months

  2. Progression to end stage renal disease (eGFR<15ml/min/1.73 m2, dialysis or transplantation)

    Time frame: 120 months

  3. Death

    Time frame: 120 months

Secondary outcomes

  1. Remission of proteinuria (complete or partial)

    Time frame: 120 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xue Qing Yu, M.D. & Ph.D.

CONTACT

[email protected]

8620-87766335

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Acronym: INTEREST

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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