NCT02954419

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Nov 2016Jan 2027

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

November 2, 2016

Last Update Submit

April 8, 2026

Conditions

IgA NephropathyGlomerular Diseases

Keywords

IgA NephropathyBiomarker

Outcome Measures

Primary Outcomes (3)

  • A doubling of serum creatinine level from baseline

    120 months

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

    120 months

  • Death

    120 months

Secondary Outcomes (1)

  • Remission of proteinuria (complete or partial)

    120 months

Study Arms (1)

IgA nephropathy group

Eligible biopsy-proven primary IgA nephropathy patients.

Other: No intervention

Interventions

No interventionOTHER

No intervention

IgA nephropathy group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with biopsy-proven primary IgA nephropathy

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples of the patients are collected.

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Xue Qing Yu, M.D. & Ph.D.

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

8620-87766335yuxq@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 3, 2016

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CN(1)