A Study of the Prevalence of Apolipoprotein L1 (APOL1) Alleles Among Individuals With Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origin

  • STATUS
    Recruiting
  • sponsor
    Vertex Pharmaceuticals Incorporated
Send
Updated on 29 July 2021
See if I qualify
diabetes

Summary

A Study of the Prevalence of Apolipoprotein L1 (APOL1) Alleles Among Individuals With Proteinuric Kidney Disease

Description

This is a study of the prevalence of APOL1 alleles in adults who are of recent African ancestry or geographic origin. The study will enroll 2 groups of up to approximately 250 subjects each.

Group 1 includes subjects with FSGS, and Group 2 includes subjects with pNDKD. No study drug will be administered. A blood sample will be collected for APOL1 genotyping. A saliva sample will be collected for exploratory use in APOL1 genotyping assay development.

Details
Condition Proteinuria, Kidney Disease
Clinical Study IdentifierTX278499
SponsorVertex Pharmaceuticals Incorporated
Last Modified on29 July 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Willing to sign and date an informed consent form (ICF) or provide electronic informed consent, as applicable by local law
Males and females with FSGS or pNDKD who are ≥18 years old
Subject is of African ancestry or geographic origin, which may include but is not limited to the following: Black, Caribbean, African American, SubSaharan African, or LatinX
Subjects must meet one of the below criteria: a.) Group 1: Biopsy-proven FSGS; b.) Group 2: Presence of chronic NDKD (defined as having kidney disease that is not attributable to infection, neoplasia, drugs, immunological disorders or diabetes)
Subject must have previously documented proteinuria as follows: a.) Group 1: urine protein to creatinine ratio ≥1 g/g or proteinuria of ≥1 g/24 h; b.) Group 2: urine protein to creatinine ratio ≥0.1 g/g or proteinuria of ≥0.1 g/24 h

Exclusion Criteria

Subject, or close relative of the subject, is the investigator or a subinvestigator, research assistant, study coordinator, or other staff directly involved with the conduct of the study at that site
Subject has end-stage kidney disease, defined as being on chronic dialysis
Subject has had a kidney transplant
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

diabetes

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note