Trial studying safety and effects for Kidney Diseases
Official title Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT06291116
What this study is testing
What is standard care + rotigotine at 4 mg/24h for 24 months.?
standard care + rotigotine at 4 mg/24h for 24 months. is an investigational medicine, applied to the skin, being studied as a potential treatment for kidney diseases.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking at how well patients tolerate rotigotine over time and whether it shows any early signs of helping kidney function.
- Who it's for
- Adults who have autosomal dominant polycystic kidney disease.
- What's involved
- Participants will wear a small rotigotine patch on their skin each day and attend clinic visits for safety checks, blood and urine tests, and other routine examinations.
- Time commitment
- The trial runs for several months, with regular visits (often monthly) to the study site.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Amiens, France
- Caen, France
- Lille, France
- Rouen, France
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, but 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 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Amiens, France; Caen, France; Lille, France; Rouen, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.