NCT06193616 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Caroli A, Perico N, Perna A, Antiga L, Brambilla P, Pisani A, Visciano B, Imbriaco M, Messa P, Cerutti R, Dugo M, Cancian L, Buongiorno E, De Pascalis A, Gaspari F, Carrara F, Rubis N, Prandini S, Remuzzi A, Remuzzi G, Ruggenenti P; ALADIN study group
Effect of longacting somatostatin analogue on kidney and cyst growth in autosomal dominant polycystic kidney disease (ALADIN): a randomised, placebo-controlled, multicentre trial. Lancet. 2013 Nov 2;382(9903):1485-95. doi: 10.1016/S0140-6736(13)61407-5. Epub 2013 Aug 21.
Perico N, Ruggenenti P, Perna A, Caroli A, Trillini M, Sironi S, Pisani A, Riccio E, Imbriaco M, Dugo M, Morana G, Granata A, Figuera M, Gaspari F, Carrara F, Rubis N, Villa A, Gamba S, Prandini S, Cortinovis M, Remuzzi A, Remuzzi G; ALADIN 2 Study Group
Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial. PLoS Med. 2019 Apr 5;16(4):e1002777. doi: 10.1371/journal.pmed.1002777. eCollection 2019 Apr.
Trillini M, Caroli A, Perico N, Remuzzi A, Brambilla P, Villa G, Perna A, Peracchi T, Rubis N, Martinetti D, Caruso M, Leone VF, Cugini D, Carrara F, Remuzzi G, Ruggenenti P; TOOL Study Group
Effects of Octreotide-Long-Acting Release Added-on Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease: Pilot, Randomized, Placebo-Controlled, Cross-Over Trial. Clin J Am Soc Nephrol. 2023 Feb 1;18(2):223-233. doi: 10.2215/CJN.0000000000000049.

Evaluating Baseline Predictors Including Total Kidney Volume, of Chronic GFR Decline and Other Clinical Outcomes in Outpatients With ADPKD and Stage IV CKD on Chronic Treatment With Octreotide LAR: a Retrospective, Observational Study

Details for clinical trial NCT06193616

Clinical trial NCT06193616 - References