NCT06291116RecruitingPhase 2
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 12 May 2026
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06291116
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 12 May 2026 to the primary completion date, 1 Jul 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Lab values
- 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%
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CHRU de CAEN Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.