Safety of rotigotine in patients with autosomal dominant polycystic kidney disease - ETERNAL-PKD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

20 Mar 2026 → ongoing

Decision date (initial)

2025-01-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety of rotigotine administered at a dose of 4 mg/24 hours for 24 months in patients with ADPKD.

Secondary objectives 6

1. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to slow the progression of ADPKD (renal volume and renal function) compared to patients not receiving rotigotine
2. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to reduce blood pressure compared to patients not receiving rotigotine
3. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to improve quality of life compared to patients not receiving rotigotine
4. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to improve urinary markers of ADPKD progression
5. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to evaluate compliance with treatment over 24 months
6. Demonstrate that chronic administration of rotigotine at 4 mg/24 hours for 24 months in patients with ADPKD allows to evaluate the long-term tolerance of the treatment (at 24 months)

Conditions and MedDRA coding

Kidney Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. - ADPKD patients aged 18 to 60 years
2. - Normotensive or hypertensive patients treated controlled (SBP/DBP on diurnal ABPM <135/85 mmHg and/or mean ABPM <130/80 mmHg less than 3 months old)

Exclusion criteria 15

1. - Stage 4 or 5 renal insufficiency (GFR CKD-EPI<30 ml/min/1.73m2)
2. - History of addictive behavior, particularly gambling, compulsive purchasing or hypersexuality
3. - Drug addiction or suspected illicit drug use
4. - Taking other sedative medications or other central nervous system depressants (benzodiazepines, antipsychotics, antidepressants) - Known allergy to sulphites
5. - Contraindication to NEUPRO
6. - Contraindication to MRI
7. - Renal transplant patients
8. - Dialysis patients
9. - History of myocardial infarction or stroke less than 6 months old
10. - Severe hepatic insufficiency (Child-Pugh class C)
11. - Patients currently being treated or treated in the 6 months preceding the trial with a dopamine agonist or antagonist (L-dopa, neuroleptics, metoclopramide)
12. - Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF <30%
13. - Orthostatic hypotension (decrease in SBP > 20 mm Hg and/or DBP > 10 mm Hg)
14. - Excessive alcohol consumption (greater than 20 g/day)
15. Known allergy to sulfites

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

1. 1.a. Evaluate the change in 24 months in total renal volume measured by height-adjusted MRI 1.b. Evaluate the variation in glomerular filtration rate (GFR) over 24 months estimated by the CKD-EPI formula
2. 2. Evaluate the variation in blood pressure over 24 months by 24-hour ABPM
3. 3. Evaluate the change in quality of life over 24 months using the ADPKD-IS (Appendix 2)
4. 4. Evaluate the variation over 24 months in urinary markers of ADPKD progression (copeptin, cAMP, MCP-1, AQP-2)
5. 5) Evaluate treatment compliance over 24 months by calculating the discontinuity rate.
6. 6) Evaluate the proportion of patients who answered yes (and respectively no) to the question: “Would you tolerate this treatment for the rest of your life?” »

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Nell Marty

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Nell Marty

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications