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โ† Trials
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Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease

RecruitingPhase 2Ages 18 Years - 60 YearsAllUniversity Hospital, Rouen
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In plain words

What the trial is, and whether it could suit you

Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and is caused by mutations in the PKD1 or PKD2 genes, which encode polycystins 1 and 2. Patients develop renal cysts associated with a progressive decline in kidney function, ultimately leading to end-stage renal disease in approximately one third of cases. ADPKD is also characterized by early-onset hypertension and cardiovascular complications, notably intracranial aneurysms. This phenotype is related to abnormal polycystin function in the primary cilia of renal epithelial and vascular endothelial cells, resulting in impaired mechanotransduction of shear stress induced by urinary and blood flow and subsequent alterations in multiple cellular functions. Experimental studies have suggested that stimulation of dopamine receptor type 5 (DR5) may restore endothelial mechanosensitivity. This hyp

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * ADPKD patients aged 18 to 60 years * Normotensive or hypertensive patients treated controlled (SBP/DBP on daytime ABPM \<135/85 mmHg less than 3 months old) * Patient having read and understood the information letter and signed the consent form * Effective contraception in women of childbearing age (for postmenopausal women, a confirmatory diagnosis should be obtained) * Patient benefiting from a social protection scheme Exclusion Criteria: * Stage 4 or 5 renal insufficiency (GFR CKD-EPI \<30 ml/min) * Renal transplant patients * Dialysis patients * History of myocardial infarction or stroke less than 6 months old * Severe hepatic insufficiency (Child-Pugh class C) * Patients currently being treated or treated in the 6 months preceding the trial with a dopamine agonist or antagonist * Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF \<30% * Orthostatic hypotension (decrease \> 20 mm Hg) * Pregnant, breastfeeding woman, or proven absence of contraception * Excessive alcohol consumption (greater than 20 g/day) * History of addictive behavior, particularly gambling, compulsive purchasing or hypersexuality * Drug addiction or suspected illicit drug use * Taking other sedative medications or other central nervous system depressants (benzodiazepines, antipsychotics, antidepressants or neuroleptics with antiemetic intent) * Hypersensitivity to the active ingredient, rotigotine, or to one of its excipients * Known allergy to sulphites * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship.
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What it tests

  • standard care + rotigotine at 4 mg/24h for 24 months.
  • standard care for 24 months.
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Where

4 sites
CHU d'AMIENS
Amiens, France
CHRU de CAEN
Caen, France
CHU de LILLE
Lille, France
CHU de ROUEN
Rouen, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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