Hyponatreamia SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) Overhydration Autosomal dominant polycystic kidney disease MedDRA version: 17.0 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT Classification code 10040626 Term: SIADH System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Other descriptive name: TOLVAPTAN
Concentration unit
Sponsors
University Clinic in Nephrology and Hypertension, Department of Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Caucasian men and women 2) Age between 18-65 years 3) ADPKD, diagnosed by genetic testing of PKD1 (>85%) or PKD2 mutations, or by ultrasonography: a) patients with negative family history for ADKPD and more than 10 cysts in each kidney and no extrarenal or renal findings that suggest causes to cyst formation. b) patients with positive family history for ADPKD: • 15-39 yr of age and at least 3 or more unilateral or bilateral. • 40-59 yr of age and 2 or more cysts in each kidney. • 60 yr of age and at least 4 cysts in each kidney. 4) Kidney function corresponding to CKD stages 1-3(eGFR> 30 mL/min/1,73 m2) 5) BMI between 18.5 and 30 kg/m2. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease, 2) clinically significant abnormalities in blood or urine sample at the inclusion 3) previous cerebrovascular insults, 4) previous clinical evidence for aneurysm 5) Alcohol or drug abuse, 6) smoking, 7) pregnancy or breastfeeding, 8) clinically significant changes in the electrocardiogram, 9) medication except antihypertensive agents and oral contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of tolvaptan on the nitroc oxide system.;Secondary Objective: The purpose of the present study is to measure the effects of tolvaptan and octreotide on (1) renal function (GFR, u-AQP2, u-ENAC?, CH2O, u-cAMP, FENa), (2) vasoactive hormones (p-AVP, p-Aldo, PRC, Ang.II, p-ANP, endot-I and p-BNP), and (3) central haemodynamics (central blood pressure, pulse wave velocity and augmentation index), under basal conditions and during inhibition of NO in ADPKD patients. ;Primary end point(s): CH2O ( free water clearance) ;Timepoint(s) of evaluation of this end point: End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Renal function (GFR, u-AQP2, u-ENAC?, CH2O, u-cAMP, FENa), 2) vasoactive hormones (p-AVP, p-Aldo, PRC, Ang.II, p-ANP, endot-I and p-BNP), 3) central haemodynamics (central blood pressure, pulse wave velocity and augmentation index) and 4) renal clearance of nitrite and nitrate (u-nitrite, u-nitrate, p-nitrite, p-nitrate).;Timepoint(s) of evaluation of this end point: End of study. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Medical Research
Holstebro Hospital
Outcome results
None listed