NCT04858724

Brief Summary

  1. 1.Establish an IgAN cohort collaboration group and expert committee to carry out registration research.
  2. 2.Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis.
  3. 3.Establish a standardized IgAN database for combined Hospital Information System and the big data platform of the Medical Federation.
  4. 4.Develop IgAN database managements and open standards for data sharing, and carry out high-quality clinical or basic research.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration 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 Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

April 19, 2021

Last Update Submit

May 24, 2024

Conditions

Keywords

IgANdatabasemulticenter

Outcome Measures

Primary Outcomes (3)

  • The proportion of a decline in estimated glomerular filtration rate by > 50% from baseline

    To evaluate the renal function

    1 year

  • The proportion of doubling serum creatinine compared with baseline

    To evaluate the renal function

    1 year

  • Incidence of ESRD

    To evaluate the renal function

    1 year

Secondary Outcomes (2)

  • Incidence of cardiovascular events

    1 year

  • Incidence of All-cause death

    1 year

Eligibility Criteria

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

Biopsy-proven primary IgAN patients

You may qualify if:

  • No age limit, no gender limit;
  • Kidney biopsy confirmed primary IgA nephropathy;
  • Sign the informed consent form voluntarily

You may not qualify if:

  • IgA nephropathy is secondary to systemic diseases such as systemic lupus erythematosus and allergic purpura;
  • IgAN is clinically diagnosed but not confirmed by pathology;
  • The patient refuses to participate;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

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

  • Jingyuan Xie

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xie

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 26, 2021

Study Start

December 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations