NCT04947813

Brief Summary

Alport syndrome (AS) is caused by pathogenic variants in the type IV collagen genes COL4A3, COL4A4, and COL4A5. This study aims to enroll families and patients with a history of renal hematuria in 27 hospitals and detect these three genes for AS screening. This study also aims to analysis the effect of COL4A3/COL4A4/COL4A5 genotype on the development of kidney disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
8,165

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2021

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 Progress53%
Jan 2021Dec 2030

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

July 1, 2021

Status Verified

May 1, 2021

Enrollment Period

5 years

First QC Date

June 3, 2021

Last Update Submit

June 24, 2021

Conditions

Alport Syndrome

Outcome Measures

Primary Outcomes (1)

  • Identification COL4A3/COL4A4/COL4A5 variants of Alport Syndrome

    To characterize the variants of COL4A3/COL4A4/COL4A5 in patients with Alport syndrome over the course of up to 240 weeks

    Up to 240 weeks

Secondary Outcomes (1)

  • Identification genotype-phenotype correlations of Alport Syndrome

    Up to 240 weeks

Eligibility Criteria

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

Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and other 26 hospitals of China Huadong Region.

You may qualify if:

  • Age: up to 99 Years (Child, Adult, Older Adult)
  • Sex: All;
  • Families and patients with a history of renal hematuria;
  • Those who signed the informed consent.

You may not qualify if:

  • Polycystic kidney disease, hypertensive nephropathy, etc.;
  • Kidney biopsy is diagnosed as other primary/secondary kidney disease without type IV collagen-related kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephritis, etc.
  • Incomplete medical history or clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Nephritis, Hereditary

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNephritisKidney DiseasesUrologic DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

July 1, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

July 1, 2021

Record last verified: 2021-05

Locations

CN(1)