Taking people in FrancePhase 2

Tests rotigotine patch for safety in polycystic kidney disease

Tests a dopamine patch, rotigotine, in adults with kidney cysts over 24 months.

Key facts

Who runs it: University Hospital, Rouen
Where: Amiens, Caen, Lille, and Rouen, FranceSee the 4 sites
Trial code: NCT06291116
Registry title: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
Status: Recruiting
Phase: Phase 2
People taking part: 120 people, planned
Started: 12 May 2026
Expected to end: 1 Jul 2030
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: standard care + rotigotine at 4 mg/24h for 24 months.
standard care for 24 months.
Record updated: 9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 with autosomal dominant polycystic kidney disease (ADPKD) whose blood pressure is normal or well controlled. It tests the long-term safety of rotigotine patches.

Age: 18 to 60 years
Sex: Women and men can join.
Disease stage: ADPKD (a hereditary kidney disease with cysts). Kidney function must not be at stage 4 or 5 (GFR CKD-EPI under 30 ml/min).
Earlier treatment: Cannot have been treated with a dopamine agonist or antagonist now or in the 6 months before the trial. If you have high blood pressure, it must be treated and controlled.
Biomarker or test result: Daytime blood pressure monitoring (ABPM) under 135/85 mmHg, less than 3 months old.

Main reasons for not taking part

Kidney transplant or dialysis
Heart attack or stroke less than 6 months ago
Severe liver failure (Child-Pugh class C)
Pregnant or breastfeeding, or no effective contraception
History of addictive behavior, drug addiction or excessive alcohol use

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

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

Who cannot take part

Renal transplant patients
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)
History of myocardial infarction or stroke less than 6 months old
Severe hepatic insufficiency (Child-Pugh class C)
History of addictive behavior, particularly gambling, compulsive purchasing or hypersexuality
Hypersensitivity to the active ingredient, rotigotine, or to one of its excipients
Known allergy to sulphites
Stage 4 or 5 renal insufficiency (GFR CKD-EPI <30 ml/min)
Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF <30%
Dialysis patients
Patients currently being treated or treated in the 6 months preceding the trial with a dopamine agonist or antagonist
Orthostatic hypotension (decrease > 20 mm Hg)
Pregnant, breastfeeding woman, or proven absence of contraception
Excessive alcohol consumption (greater than 20 g/day)
Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 60 years old?

Where in France

CHU D'amiensAmiens, FranceContact: Gabriel Choukroun, DrTaking people
CHRU de CAENCaen, FranceContact: Clémence Bechade, DrTaking people
CHU de LilleLille, FranceContact: François-Xavier Glowacki, DrTaking people
CHU de RouenRouen, FranceContact: Dominique Guerrot, PrTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 hypothesis is supported by our preliminary results showing that local administration of dopamine improves endothelial function in patients with ADPKD through restoration of nitric oxide (NO) release in response to increased blood flow.

Consistent with these findings, the IMPROVE-PKD study recently demonstrated similar beneficial effects on endothelial function and hemodynamics using rotigotine, a dopamine agonist administered via transdermal patches for two months at a low dose (4 mg/24 h). Dopaminergic stimulation may also prevent renal abnormalities related to polycystin deficiency. We therefore hypothesize that rotigotine could slow the progression of ADPKD at both the renal and cardiovascular levels.

This phase 2 study aims to evaluate the long-term tolerability of rotigotine in patients with ADPKD and to collect preliminary data on its effects on renal outcomes.

The 2 groups in the trial

experimentalTreatment being tested
Experimental group: standard care + rotigotine at 4 mg/24 hours for 24 months.
Treatment: standard care + rotigotine at 4 mg/24h for 24 months.
ControlExisting treatment, for comparison
Control group: standard care for 24 months.
Treatment: standard care for 24 months.