Kidney Disease
Conditions
Brief summary
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.
Detailed description
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. Evaluate the variation in blood pressure over 24 months by 24-hour ABPM, 3. Evaluate the change in quality of life over 24 months using the ADPKD-IS (Appendix 2), 4. Evaluate the variation over 24 months in urinary markers of ADPKD progression (copeptin, cAMP, MCP-1, AQP-2), 5) Evaluate treatment compliance over 24 months by calculating the discontinuity rate., 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?” »
Interventions
DRUGNeupro 4 mg/24 h transdermal patch
Sponsors
Centre Hospitalier Universitaire Rouen
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. Evaluate the variation in blood pressure over 24 months by 24-hour ABPM, 3. Evaluate the change in quality of life over 24 months using the ADPKD-IS (Appendix 2), 4. Evaluate the variation over 24 months in urinary markers of ADPKD progression (copeptin, cAMP, MCP-1, AQP-2), 5) Evaluate treatment compliance over 24 months by calculating the discontinuity rate., 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?” » | — |
Countries
France
Outcome results
None listed