Same as above

Subacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004115-39-DK

Enrollment

Registered

2017-12-13

Start date

2018-02-08

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

Autosomal Dominant Polycystic Kidney DIsease MedDRA version: 20.0 Level: LLT Classification code 10036045 Term: Polycystic kidney System Organ Class: 100000004850

Interventions

Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 15 or 45 mg Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 15068

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients aged between 18 and 65 years Diagnosis of typical ADPKD tKV above or equal to 750 ml by MRI scanning Estimated GFR (e-GFR) by CKD-SPI formula of above or equal to 45mL/min/1.73m2 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 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Kidney transplant recipient Known liver disease except for liver cysts relating to ADPKD ASAT and ALAT above upper normal level Current treatment with thiazide and thiazide-like diuretics, mineralcortocoid receptor antagonists, amiloride or loop diuretics Evidence of urinary tract obstruction Current treatment with CYP3A4 inhibitors Active malignant disease Current or previous treatment with tolvaptan

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether six weeks treatment with tablet tolvaptan is more efficient than no tolvaptan treatment on reduction of tKV in patients with Autsomal Dominant Polycystic Kidney Disease (ADPKD).;Secondary Objective: The secondary objectives of the trial are to evaluate the effect of six weeks treatment with tablet tolvaptan versus no tolvaptan treatment on CrEDTA measured glumerular filtration rate (GFR) and safety.;Primary end point(s): Change in total kidney volume (tKV) measured by MRI scanning between baseline and six weeks ;Timepoint(s) of evaluation of this end point: After six weeks	—

Measure

Time frame

Main Objective: To evaluate whether six weeks treatment with tablet tolvaptan is more efficient than no tolvaptan treatment on reduction of tKV in patients with Autsomal Dominant Polycystic Kidney Disease (ADPKD).;Secondary Objective: The secondary objectives of the trial are to evaluate the effect of six weeks treatment with tablet tolvaptan versus no tolvaptan treatment on CrEDTA measured glumerular filtration rate (GFR) and safety.;Primary end point(s): Change in total kidney volume (tKV) measured by MRI scanning between baseline and six weeks ;Timepoint(s) of evaluation of this end point: After six weeks

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Secondary

Measure	Time frame
Secondary end point(s): Change between baseline and six weeks in: • GFR – measured by Cr-EDTA clearance • relevant genetic and non-genetic biomarkers • Quality of Life – estimated by questionnaires • plasma ASAT and ALAT • incidence of Adverse Events (AE) Change between baseline and 12 weeks (= end of trial) in: • tKV • GFR – measured by Cr-EDTA clearance • relevant genetic and non-genetic biomarkers • Quality of Life – estimated by questionnaires • plasma ASAT and ALAT • incidence of Adverse Events ;Timepoint(s) of evaluation of this end point: Please see in E.5.2 which parameter will be measured after six and 12 weeks.	—

Measure

Time frame

Secondary end point(s): Change between baseline and six weeks in: • GFR – measured by Cr-EDTA clearance • relevant genetic and non-genetic biomarkers • Quality of Life – estimated by questionnaires • plasma ASAT and ALAT • incidence of Adverse Events (AE) Change between baseline and 12 weeks (= end of trial) in: • tKV • GFR – measured by Cr-EDTA clearance • relevant genetic and non-genetic biomarkers • Quality of Life – estimated by questionnaires • plasma ASAT and ALAT • incidence of Adverse Events ;Timepoint(s) of evaluation of this end point: Please see in E.5.2 which parameter will be measured after six and 12 weeks.

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Countries

Denmark

Contacts

Public ContactLisbet Brandi

Nordsjællands Hospital

lisbet.brandi@regionh.dk4548295993

Outcome results

None listed

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