Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU d'AMIENS, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard care + rotigotine at 4 mg/24h for 24 months.

Drug

standard care + rotigotine at 4 mg/24h for 24 months.

standard care for 24 months.

Drug

standard care for 24 months.

Primary outcomes

Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD

Time frame: throught 24 months

Safety is defined by the occurrence of adverse events (AvE) and the occurrence of serious adverse events (SvA) for 24 months. The main safety criterion is based on the proportion of participants who experienced at least one EvIG during the 24 months of study follow-up such as the occurrence of serious reactions at the application site or certain behavioral disorders.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Guerrot, Pr

CONTACT

[email protected]

02 32 88 54 46

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ETERNAL-PKD

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Mar 4, 2024
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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