Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney disease

Effect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001903-30-DK

Enrollment

Registered

2015-05-13

Start date

2015-06-26

Completion date

Unknown

Last updated

2018-01-29

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

Conditions

Adult dominant polycystic kidney disease (ADPKD) MedDRA version: 20.0 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 100000004850

Interventions

Trade Name: Samsca Pharmaceutical Form: Chewable tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years Diagnosis with ADPKD Informed consent Contraception for fertile women 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Renal transplantation • Operation in the kidnety • Diabetes mellitus • Neoplastic conditions • Pregnancy, nursing • Unwillingness to participate • eGFR > 30 • Intolerans towrds tolvaptan • Alkohol or medical abuse, • BP >>170/110 blodtryk despite regulation

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD;Secondary Objective: The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD;Primary end point(s): RPF;Timepoint(s) of evaluation of this end point: End of trial	—

Secondary

Measure	Time frame
Secondary end point(s): GFR, RVR, FF Brachial and central BP PRC, p-Ang-II, p-Aldo, p-AVP Urinflow, u-Na, u-K, u-albumin, u-creatinin, u-osmolalitet, u-AQP-2 in 24 hour urine ;Timepoint(s) of evaluation of this end point: End of study	—

Countries

Denmark

Contacts

Public ContactFrank Mose

Department of Medical Research

frchri@rm.dk+4528531257

Outcome results

None listed

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