Rotigotine for Autosomal dominant polycystic kidney disease

Inclusion criteria

• {"criterion_text":"- ADPKD patients aged 18 to 60 years\n- 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

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Safety defined by occurrence of adverse reactions (AEs) and serious adverse reactions (SAEs) over 24 months; main criterion = proportion of participants experiencing at least one SAE during 24 months (including serious reactions at application site or certain behavioral disorders)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"1.a Total renal volume measured by height-adjusted MRI over 24 months; 1.b GFR variation over 24 months estimated by CKD-EPI formula."}
• {"endpoint_text":"- 2. Evaluate the variation in blood pressure over 24 months by 24-hour ABPM","definition_or_measurement_approach":"Change in blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) over 24 months."}
• {"endpoint_text":"- 3. Evaluate the change in quality of life over 24 months using the ADPKD-IS (Appendix 2)","definition_or_measurement_approach":"Quality of life assessed using the ADPKD-IS instrument over 24 months."}
• {"endpoint_text":"- 4. Evaluate the variation over 24 months in urinary markers of ADPKD progression (copeptin, cAMP, MCP-1, AQP-2)","definition_or_measurement_approach":"Measurement of urinary biomarkers (copeptin, cAMP, MCP-1, AQP-2) and their change over 24 months."}
• {"endpoint_text":"- 5) Evaluate treatment compliance over 24 months by calculating the discontinuity rate.","definition_or_measurement_approach":"Treatment compliance evaluated by calculating discontinuity rate over 24 months."}
• {"endpoint_text":"- 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?” »","definition_or_measurement_approach":"Proportion of patients responding yes/no to the specified tolerability question."}

France

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

53

Number Of Sites

4

Number Of Participants

120

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France