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 - Study of APOL1 in Individuals With Kidney Disease

Vertex Pharmaceuticals0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月9日

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•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),
•b. urine albumin-to-creatinine ratio (UACR) >=0.3 g/g (>=300 mg/g; >=30 mg/mmol),
•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

•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.

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