Overview

Effect of the Aquaretic Tolvaptan on Nitric Oxide System

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones. The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant polycystic kidney disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Regional Hospital Holstebro
Collaborator:
Aarhus University Hospital
Treatments:
Nitric Oxide
Tolvaptan
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:

1. 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.

2. 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 35.5 kg/m2.

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,

10. blood pressure>170/105 mmHg despite treatment with metoprolol and/or amlodipine.