A Study of the Prevalence of Apolipoprotein L1(APOL1) Alleles Among Individuals With Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origi
- Conditions
- Proteinuric Kidney Disease10038360
- Registration Number
- NL-OMON51493
- Lead Sponsor
- Vertex Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1. Willing to sign and date an informed consent form (ICF) either in-person or
remotely, as applicable by local law.
2. Participants aged 12 to 65 years (inclusive).
3. Participant is of African ancestry or geographic origin, which may include
but is not limited to the following: Black, Caribbean, African American,
Sub-Saharan African, or LatinX (defined as a person of Cuban, Mexican, Puerto
Rican, South or Central American, or other Spanish culture or origin).
4. Participants must meet one of the below criteria:
a. Group 1: FSGS.
b. Group 2: Presence of proteinuric nondiabetic CKD (not attributable to
infection, neoplasia, drugs, autoimmune disorders, or diabetes).
c. Group 3: Individuals* without a documented CKD diagnosis, but with a
historical eGFR of <75 mL/min.
*Including, but not limited to first degree blood relatives (i.e., parent, full
sibling, or child) of individuals with end-stage kidney disease (ESKD).
5. Proteinuria as defined by at least one of the following:
a. urine protein to creatinine ratio (UPCR) >=0.5 g/g (>=500 mg/g; >=50 mg/mmol),
or
b. urine albumin-to-creatinine ratio (UACR) >=0.3 g/g (>=300 mg/g; >=30 mg/mmol),
or
c. urine dipstick analysis with protein reagent strip >=1+
Proteinuria can be confirmed via:
• previously documented result if it was done within 12 months before the date
of informed consent OR
• by a random spot urine sample using a dipstick test performed during
screening.
1. Participant, or close relative of the participant, is the investigator or a
subinvestigator, research assistant, study coordinator, or other staff directly
involved with the conduct of the study at that site.
2. ESKD, defined as being on chronic dialysis.
3. Prior kidney transplant.
4. History of diabetes mellitus.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Estimate the prevalence of APOL1 genotypes among individuals with focal<br /><br>segmental glomerulosclerosis (FSGS) who identify themselves as being of recent<br /><br>African ancestry or geographic origin<br /><br>• Estimate the prevalence of APOL1 genotypes among individuals with other forms<br /><br>of proteinuric nondiabetic chronic kidney disease (CKD) who identify themselves<br /><br>as being of recent African ancestry or geographic origin<br /><br>• Estimate the prevalence of APOL1 genotypes in individuals without a<br /><br>documented CKD diagnosis, but with a historical eGFR of <75 mL/min who identify<br /><br>themselves as being of recent African ancestry or geographic origin</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Identify individuals with FSGS and 2 APOL1 risk alleles to establish a group<br /><br>of potential participants for current and future Vertex clinical studies<br /><br>• Identify individuals with other forms of proteinuric nondiabetic CKD and 2<br /><br>APOL1 risk alleles to establish a group of potential participants for current<br /><br>and future Vertex clinical studies</p><br>