BridgeMD
Safety of rotigotine in patients with autosomal dominant polycystic kidney disease - ETERNAL-PKD
EU CTIS ID: 2024-515734-32-00
What this study is testing
To evaluate the safety of rotigotine administered at a dose of 4 mg/24 hours for 24 months in patients with ADPKD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - ADPKD patients aged 18 to 60 years
- - 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)
You likely can't join if
- - Stage 4 or 5 renal insufficiency (GFR CKD-EPI<30 ml/min/1.73m2)
- - 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 (L-dopa, neuroleptics, metoclopramide)
- - Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF <30%
- - Orthostatic hypotension (decrease in SBP > 20 mm Hg and/or DBP > 10 mm Hg)
- - Excessive alcohol consumption (greater than 20 g/day)
See the full eligibility criteria
- - ADPKD patients aged 18 to 60 years
- - 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)
- - Stage 4 or 5 renal insufficiency (GFR CKD-EPI<30 ml/min/1.73m2)
- - 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 (L-dopa, neuroleptics, metoclopramide)
- - Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF <30%
- - Orthostatic hypotension (decrease in SBP > 20 mm Hg and/or DBP > 10 mm Hg)
- - Excessive alcohol consumption (greater than 20 g/day)
- Known allergy to sulfites
- - 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) - Known allergy to sulphites
- - Contraindication to NEUPRO
- - Contraindication to MRI
- - Renal transplant patients
- - Dialysis patients
- - History of myocardial infarction or stroke less than 6 months old
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.