Rotigotine in adults with autosomal dominant polycystic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial investigates the safety and potential benefits of rotigotine at 4 mg per day added to standard care in adults with ADPKD. Eligible participants are 18 to 60 years old, with preserved or well-controlled blood pressure, and without advanced kidney failure or recent major cardiovascular events. Participants will receive standard care plus rotigotine for 24 months, with ongoing monitoring of kidney function, cardiovascular health, and other safety parameters. The study is conducted across French centers in Amiens, Caen, and Lille under the lead sponsorship of University Hospital, Rouen. Outcomes will inform whether dopamine receptor 5 stimulation can mitigate endothelial dysfunction and progression markers in ADPKD.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU d'AMIENS
  Amiens, France Recruiting
• CHRU de CAEN
  Caen, France Recruiting
• CHU de LILLE
  Lille, France Recruiting
• CHU de ROUEN
  Rouen, France Recruiting

Study contacts

• Study coordinator: Dominique Guerrot, Pr
• Email: Dominique.Guerrot@chu-rouen.fr
• Phone: 02 32 88 54 46

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.