Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil

Treatment of congenital nephrogenic diabetes insipidus with a guanylate cyclase stimulator, riociguat or a phosphodiesterase type 5 inhibitor, sildenafil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001591-30-DK

Enrollment

Registered

2017-03-09

Start date

2017-11-06

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Adempas Product Name: Adempas Pharmaceutical Form: Tablet INN or Proposed INN: RIOCIGUAT CAS Number: 625115-55-1

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Urinary output pr. hour;Timepoint(s) of evaluation of this end point: Immediately after the test period; 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 ;Secondary Objective: Not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): Fluid intake;Timepoint(s) of evaluation of this end point: Immediately after the test period	—

Countries

Denmark

Contacts

Public ContactDept. of Nephrology

Odense University Hospital

ode.y@rsyd.dk4565411106

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026