Effect of the Aquaretic Tolvaptan on Nitric Oxide System | NCT02527863

Studies
Effect of the Aquaretic Tolvaptan on Nitric Oxide System

NCT02527863

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

18Actual

Phase

Phase 2

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

Tolvaptan
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-001973-15	EudraCT Number

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Feb 18, 2015

First Submission Date that Met QC Criteria

Aug 17, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
60 mg Tolvaptan	Active Comparator	Oral administration of 60 mg tolvaptan on each examination day.	Drug: Tolvaptan
Placebo	Placebo Comparator	Oral administration of a Unikalk tablet.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tolvaptan	Drug	60 mg Tolvaptan pr day for 1 day	60 mg Tolvaptan	Samsca

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CH2O (Measurement of H2O clearance)	Measurement of H2O clearance at baseline, during and after L-NMMA infusion	5-6 Hours

Secondary Outcomes

Measure	Description	Time Frame
Urine biomarkers(Aquaporins and Epithelial Sodium Channels γ)		5-6 Hours
Central and brachial blood pressure		5-6 Hours
Augmentation Index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian men and women
Age between 18-65 years
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.
Kidney function corresponding to CKD stages 1-3(eGFR> 30 mL/min/1,73 m2),
BMI between 18.5 and 35.5 kg/m2.

Exclusion Criteria:

Clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease,
clinically significant abnormalities in blood or urine sample at the inclusion
previous cerebrovascular insults,
previous clinical evidence for aneurysm
Alcohol or drug abuse,
smoking,
pregnancy or breastfeeding,
clinically significant changes in the electrocardiogram,
medication except antihypertensive agents and oral contraceptives,
blood pressure>170/105 mmHg despite treatment with metoprolol and/or amlodipine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen	Department of Medical Research and Medicine, Holstebro Regional Hospital Holstebro, Holstebro, Denmark, 7500	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research and Medicine, Holstebro Regional Hospital		Holstebro	Holstebro	7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39356039	Derived	St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
28810844	Derived

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds