Proteinuric Kidney Disease
Conditions
Interventions
None listed
Sponsors
Vertex Pharmaceuticals
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 =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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Estimate the prevalence of APOL1 genotypes among individuals with focal segmental glomerulosclerosis (FSGS) who identify themselves as being of recent African ancestry or geographic origin • Estimate the prevalence of APOL1 genotypes among individuals with other forms of proteinuric nondiabetic chronic kidney disease (CKD) who identify themselves as being of recent African ancestry or geographic origin • Estimate the prevalence of APOL1 genotypes in individuals without a documented CKD diagnosis, but with a historical eGFR of | — |
Secondary
| Measure | Time frame |
|---|---|
| • Identify individuals with FSGS and 2 APOL1 risk alleles to establish a group of potential participants for current and future Vertex clinical studies • Identify individuals with other forms of proteinuric nondiabetic CKD and 2 APOL1 risk alleles to establish a group of potential participants for current and future Vertex clinical studies | — |
Countries
Netherlands
Outcome results
None listed