NCT06291116 Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
| NCT ID | NCT06291116 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Rouen |
| Condition | Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2030-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-05-12 with a primary completion date of 2030-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06291116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06291116 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06291116 currently recruiting?
Yes, NCT06291116 is actively recruiting participants. Contact the research team at Dominique.Guerrot@chu-rouen.fr for enrollment information.
Where is the NCT06291116 trial being conducted?
This trial is being conducted at Amiens, France, Caen, France, Lille, France, Rouen, France.
Who is sponsoring the NCT06291116 clinical trial?
NCT06291116 is sponsored by University Hospital, Rouen. The trial plans to enroll 120 participants.
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