Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2016-001591-30-DK
• Date of registration: 09/03/2017
• Prospective Registration: Yes
• Primary sponsor: Odense University Hospital
• Public title: Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil
• Scientific title: Treatment of congenital nephrogenic diabetes insipidus with a guanylate cyclase stimulator, riociguat or a phosphodiesterase type 5 inhibitor, sildenafil
• Date of first enrolment: 06/11/2017
• Target sample size: 2
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001591-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Dept. of Nephrology
• Affiliation: Odense University Hospital

• Name: Dept. of Nephrology
• Affiliation: Odense University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Age > 18 year
- Mentally capable of understanding the test
- Nephrogenic diabetes insipidus
- Followed at the Odense University Hospital
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 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Other known relevant disease including malignity
- Contraindications to riociguat or sildenafil (e.g. treatment with nitrovasodilators).
- Systolic blood pressure < 95mmHg


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Nephrogenic diabetes insipidus because of AVP2R-mutation
MedDRA version: 20.0 Level: LLT Classification code 10012626 Term: Diabetes nephrogenic (excludes glycosuria) System Organ Class: 100000004857

Intervention(s)

Trade Name: Adempas
Product Name: Adempas
Pharmaceutical Form: Tablet
INN or Proposed INN: RIOCIGUAT
CAS Number: 625115-55-1
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 3-

Trade Name: Viagra
Product Name: Viagra
Pharmaceutical Form: Tablet
INN or Proposed INN: SILDENAFIL
CAS Number: 139755-83-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): Urinary output pr. hour

Main Objective: The aim of the study is to test the hypothesis that treatment with riociguat or sildenafil in patients with NDI
caused by AVP2R mutation improves the symptoms by reducing diuresis

Timepoint(s) of evaluation of this end point: Immediately after the test period

Secondary Outcome(s)

Secondary end point(s): Fluid intake

Timepoint(s) of evaluation of this end point: Immediately after the test period

Secondary ID(s)

S-20150201

Source(s) of Monetary Support

funding

Ethics review

Status: Approved
Approval date:
Contact: