Effect of the Aquaretic Tolvaptan on Nitric Oxide System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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60 mg Tolvaptan

Oral administration of 60 mg tolvaptan on each examination day.

Group Type ACTIVE_COMPARATOR

Tolvaptan

Intervention Type DRUG

60 mg Tolvaptan pr day for 1 day

Placebo

Oral administration of a Unikalk tablet.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet Unikalk pr day for 1 day

Interventions

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Tolvaptan

60 mg Tolvaptan pr day for 1 day

Intervention Type DRUG

Placebo

1 tablet Unikalk pr day for 1 day

Intervention Type DRUG

Other Intervention Names

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Samsca Unikalk

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No