Effect of tolvaptan on RBF and GFR in ADPKD

INTERVENTION: Trade Name: Samsca Pharmaceutical Form: Chewable tablet INN or Proposed INN: Tolvaptan CAS Number: 150683‐30‐0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Adult dominant polycystic kidney disease (ADPKD) ; MedDRA version: 20.0 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 100000004850 Therapeutic area: Body processes [G] ‐ Physical Phenomena [G01] PRIMARY OUTCOME: Main Objective: The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD Primary end point(s): RPF Secondary Objective: The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD Timepoint(s) of evaluation of this end point: End of trial SECONDARY OUTCOME: Secondary end point(s): GFR, RVR, FF ; Brachial and central BP ; PRC, p‐Ang‐II, p‐Aldo, p‐AVP ; Urinflow, u‐Na, u‐K, u‐albumin, u‐creatinin, u‐osmolalitet, u‐AQP‐2 in 24 hour urine ; Timepoint(s) of evaluation of this end point: End of study INCLUSION CRITERIA: Age > 18 years Diagnosis with ADPKD Informed consent Contraception for fertile women Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5