Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease (NCT06291116) | Clinical Trial Compass
RecruitingPhase 2
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
France120 participantsStarted 2026-05-12
Plain-language summary
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 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD