IgA Nephropathy Biomarkers Evaluation Study (INTEREST) (INTEREST)

September 21, 2021 updated by: Xue Qing Yu, Sun Yat-sen University
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with biopsy-proven primary IgA nephropathy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IgA nephropathy group
Eligible biopsy-proven primary IgA nephropathy patients.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A doubling of serum creatinine level from baseline
Time Frame: 120 months
120 months
Progression to end stage renal disease (eGFR<15ml/min/1.73 m2, dialysis or transplantation）
Time Frame: 120 months
120 months
Death
Time Frame: 120 months
120 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Remission of proteinuria (complete or partial)
Time Frame: 120 months
120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xue Qing Yu, M.D. & Ph.D., First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGIgAN-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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