Study Completed

Alport Syndrome

Bayer Identifier:

22733

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

A study called ASPIRE using healthcare databases to better understand Alport syndrome in real-world settings

Trial purpose

The overall objective of this study is to generate insights into the epidemiology of clinical presentation, management strategies and prognosis of patients with Alport Syndrome (AS) by describing patient characteristics, treatment patterns, healthcare resource utilization (HCRU) and clinical outcomes in patients identified with AS from large real-world healthcare databases in various countries.

Key Participants Requirements

Sex

All

Age

1 - 40 Years

Inclusion Criteria

- A diagnostic code for Alport Syndrome AND
- Patient age between 1 and 40 years at index date AND
- A minimum of 12 months of continuous enrollment in the database before index date

Exclusion Criteria

- Kidney failure any time before or on the index date.
Onset of kidney failure was defined as the occurrence of any of the following:
- ≥ 2 eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days
- Records of dependence on maintenance dialysis (at least 3 sessions of hemodialysis OR 1 session of peritoneal dialysis NOT in the inpatient setting) within a period of 90 days)
- Records of chronic kidney disease (CKD) stage 5 or end-stage kidney disease (ESKD)
- Record of kidney transplant

The medical code lists for the inclusion and exclusion criteria (marked in italics) were defined based on medical concept sets consisting of Systematized Nomenclature of Medicine (SNOMED) Clinical Terms codes, RxNorm drug codes, and laboratory measurements.

Trial summary

Enrollment Goal

1838

Trial Dates

January 2024 - June 2025

Phase

N/A

Could I Receive a placebo

N/A

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
		Many locations, Japan
		Many locations, United Kingdom
		Many locations, United States

Primary Outcome

Sociodemographic characteristics: sex, age, race, ethnicity
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Comorbidities at baseline
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution

Secondary Outcome

Treatment use at baseline
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Treatment patterns after diagnosis
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Incidence rates for kidney failure, composite CV outcomes, and all-cause mortaility
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
eGFR, UACR, and UPCR at baseline and in the year before diagnosis
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Estimated mean eGFR during follow-up
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Estimated eGFR during follow-up by year
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Annual change of eGFR, UACR, and UPCR from baseline
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution
Median UACR and UPCR during follow-up
Time Frame:
Retrospective analysis of data from 01 JAN 2012 to the latest available cut-off date at the time of study execution

Trial design

ASPIRE: Alport Syndrome Patient Insights using Real-World Evidence

Trial Type

Observational

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Alport Syndrome

Trial purpose

Key Participants Requirements

Sex

Age

Trial summary

Where to participate

Primary Outcome

Secondary Outcome

Trial design

Additional Information