Japanese National RegistryPKD(JRP)

JRCT ID: jRCT1030230618

Registered date:07/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: autosomal dominant polycystic kidney disease, autosomal recessive polycystic kidney disease
• Date of first enrollment: 01/04/2024
• Target sample size: 1100
• Study type: Observational

Outcome(s)

• Primary Outcome: The primary end point from the JRP is kidney composite events, including kidney replacement therapy (hemodialysis, peritoneal dialysis and kidney transplantation), and a 50% decline in eGFR.

Secondary Outcome

Subsequent end points for patients with ADPKD include: annual rate of change in TKV, annual rate of change in eGFR, PROs, hospitalization, infection, CVD events, and all-cause mortality.
Subsequent end points for patients with ARPKD patients include: liver transplantation, all-cause mortality, intellectual disability, and schooling and employment status.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: Patients with ADPKD and ARPKD are diagnosed according to the Japanese PKD guideline criteria, or genetic information. For the ADPKD cohort, patients with an eGFR more than 15.0 will be included.
• Exclude criteria: Exclusion criteria include: history of kidney transplantation, active cancer, cancer treatment within last 5 years, or participation in a PKD-related clinical trial. If pathological or genetic examinations reveal that a patient has a type of PKD other than ADPKD or ARPKD, they will be excluded from the study, even if they have already enrolled.

Related Information

• Primary Sponsor: Muto Satoru