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Canadian Medical Assessment of JINARC™ Outcomes Registry

2016-10-06 00:38:22 | BioPortfolio

Summary

This study is part of the Health Canada approval requirement for tolvaptan and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. The study is also describing the time to renal replacement therapy (RRT), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in ADPKD patients treated with tolvatan (JINARC™)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Location

Halifax
Nova Scotia
Canada

Status

Recruiting

Source

Otsuka Canada Pharmaceutical Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-06T00:38:22-0400

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Medical and Biotech [MESH] Definitions

Kidney disorders with autosomal dominant inheritance and characterized by multiple CYSTS in both KIDNEYS with progressive deterioration of renal function.

Hereditary diseases that are characterized by the progressive expansion of a large number of tightly packed CYSTS within the KIDNEYS. They include diseases with autosomal dominant and autosomal recessive inheritance.

A genetic disorder with autosomal recessive inheritance, characterized by multiple CYSTS in both KIDNEYS and associated LIVER lesions. Serious manifestations are usually present at BIRTH with high PERINATAL MORTALITY.

A non-hereditary KIDNEY disorder characterized by the abnormally dilated (ECTASIA) medullary and inner papillary portions of the collecting ducts. These collecting ducts usually contain CYSTS or DIVERTICULA filled with jelly-like material or small calculi (KIDNEY STONES) leading to infections or obstruction. It should be distinguished from congenital or hereditary POLYCYSTIC KIDNEY DISEASES.

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