Kidney DiseasesPhase 2ETERNAL-PKDNCT06291116
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
A Phase 2 study of Kidney Diseases, run by University Hospital, Rouen at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 12 May 2026to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU d'AMIENS
Amiens, 80054
Gabriel Choukroun, Dr, 03 22 45 54 62, choukroun.gabriel@chu-amiens.fr
Gabriel Choukroun, Dr
- Recruiting
CHRU de CAEN
Caen, 14033
Clémence Bechade, Dr, 02 31 27 25 76, bechade-c@chu-caen.fr
Clémence Bechade, Dr
- Recruiting
CHU de LILLE
Lille, 59037
François-Xavier Glowacki, Dr, 03 20 44 40 75, Francois.GLOWACKI@CHRU-LILLE.FR
François-Xavier Glowacki, Dr
- Recruiting
CHU de ROUEN
Rouen, 76031
Dominique Guerrot, Pr, 02.32.88.31.21, Audrey.Dumont@chu-rouen.fr
Dominique Guerrot, Pr
About this study
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.
Read more
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.
- Conditions
- Kidney Diseases
- Being tested
- standard care + rotigotine at 4 mg/24h for 24 months., standard care for 24 months.
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Experimental group: standard care + rotigotine at 4 mg/24 hours for 24 months. Receives: Drug: standard care + rotigotine at 4 mg/24h for 24 months. |
| Control | Active comparator | Control group: standard care for 24 months. Receives: Drug: standard care for 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD
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.
Measured: throught 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start12 May 2026
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291116
- Sponsor's protocol ID
- 2022/0345/HP
- Acronym
- ETERNAL-PKD
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06291116
- Acronym / sponsor ID
- ETERNAL-PKD / 2022/0345/HP
- Conditions
- Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: standard care + rotigotine at 4 mg/24h for 24 months.Experimental group: standard care + rotigotine at 4 mg/24 hours for 24 months. |
| Control | Active comparator | Drug: standard care for 24 months.Control group: standard care for 24 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard care + rotigotine at 4 mg/24h for 24 months.standard care + rotigotine at 4 mg/24h for 24 months. | Drug | experimental |
| standard care for 24 months.standard care for 24 months. | Drug | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Individual participant dataSharing planned: No
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Kidney Diseases, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique Guerrot, Pr (02 32 88 54 46, Dominique.Guerrot@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.