Canadian Medical Assessment of JINARC™ Outcomes Registry
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)
Links
- Source: http://clinicaltrials.gov/show/NCT02925221
- ClinicalTrials.gov processed this data on October 05, 2016
Published on BioPortfolio: 2016-10-06T00:38:22-0400
Clinical Trials
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2). C...
The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosom...
Registry for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) on Tolvaptan Therapy
The Registry is observational in design and will collect data on patients with ADPKD and therapy with Tolvaptan to gain real-life information on drug safety and effectiveness as well as th...
Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards cyst growth and slows renal functional deterioration in patients with ADPKD.
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of ...
PubMed Articles
Total kidney volume, measured by magnetic resonance imaging (MRI), is a validated disease progression marker in adults with autosomal dominant polycystic kidney disease (ADPKD). However, in childhood,...
Early Markers of Cardiovascular Risk in Autosomal Dominant Polycystic Kidney Disease.
Cardiovascular disease is the most frequent cause of morbidity and mortality in autosomal dominant polycystic kidney disease (ADPKD) patients, often before the onset of renal failure, and the pathogen...
Novel semi-automated kidney volume measurements in autosomal dominant polycystic kidney disease.
We assessed the effectiveness and convenience of a novel semi-automatic kidney volume (KV) measuring high-speed 3D-image analysis system SYNAPSE VINCENT(®) (Fuji Medical Systems, Tokyo, Japan) for au...
Autosomal dominant polycystic kidney disease (ADPKD) is a common congenital chronic kidney disease (CKD). We report here the relationship of serum angiopoietin-1 (Ang-1), Ang-2, and vascular endotheli...
Sensing the texture of imaging, a new biomarker of polycystic kidney disease.
In autosomal dominant polycystic kidney disease, total kidney volume and age can identify patients with progressive disease. Texture analysis of magnetic resonance imaging that computerizes and extrac...
Medical and Biotech [MESH] Definitions
Polycystic Kidney, Autosomal Dominant
Kidney disorders with autosomal dominant inheritance and characterized by multiple CYSTS in both KIDNEYS with progressive deterioration of renal function.
Polycystic Kidney Diseases
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.
Polycystic Kidney, Autosomal Recessive
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.
Medullary Sponge Kidney
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.
Polycystic Ovary Syndrome
A complex disorder characterized by infertility, HIRSUTISM; OBESITY; and various menstrual disturbances such as OLIGOMENORRHEA; AMENORRHEA; ANOVULATION. Polycystic ovary syndrome is usually associated with bilateral enlarged ovaries studded with atretic follicles, not with cysts. The term, polycystic ovary, is misleading.
