The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney disease

Conditions: HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0Level: LLTClassification code 10021038Term: HyponatremiaSystem Organ Class: 100000004861
MedDRA version: 17.0Level: LLTClassification code 10040626Term: SIADHSystem Organ Class: 100000004860
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2014-001973-15-DK

Lead Sponsor: niversity Clinic in Nephrology and Hypertension, Department of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.