Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease
NCT ID: NCT03596957
Last Updated: 2018-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2018-09-12
2020-04-30
Brief Summary
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Patients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medication or no tolvaptan treatment, but following the same visit and investigation plan as the subjects taking tolvaptan.
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Detailed Description
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The tolvaptan tablet has been approved by EMA (European Medicines Agency) with the indication of slowing the progression of cysts development and renal insufficiency in adults with ADPKD. It is the newest and only possible treatment for this patient group and could be initiated in patients with evidence for rapidly progressive disease Development.
There is however in Denmark and other countries both scientific and financial reluctance to initiate this expensive treatment for several reasons e.g. selection of patients who might benefit, effect on progression of kidney disease, side effects and tolerability.
Before deciding on implementation in Denmark, more knowledge is needed. The results of the PoCKET trial will contribute with guidance on this decision.
Foremost the trial is designed to address not only the change in kidney volume, but the change in kidney function, which is what matters to the patients and their prognosis in terms of postponing time to end stage renal disease. Furthermore, important data on side effects and tolerability will be generated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tolvaptan group
Treatment with tolvaptan for six weeks followed by six weeks observation without trial medication
Tolvaptan
At baseline the tolvaptan dosing will start with daily morning and afternoon doses of 45 mg and 15 mg respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg according to subject tolerability
Control group
No tolvaptan treatment but following the same visit and investigation plan as the subjects in the tolvaptan group
No interventions assigned to this group
Interventions
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Tolvaptan
At baseline the tolvaptan dosing will start with daily morning and afternoon doses of 45 mg and 15 mg respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg according to subject tolerability
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of typical ADPKD
* tKV above or equal to 750 ml by MRI scanning
* Estimated GFR (e-GFR) by CKD-EPI formula of above or equal to 45 mL/min/1.73 m2
Exclusion Criteria
* Known liver disease except for liver cysts relating to ADPKD
* ASAT and ALAT above upper normal level
* Current treatment with thiazide and thiazide-line diuretics, mineral corticoid 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
18 Years
65 Years
ALL
No
Sponsors
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Lisbet Brandi
OTHER
Responsible Party
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Lisbet Brandi
Head of Department for Endrocrinology and Nephrology, MD, DMSc, MHM
Principal Investigators
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Lisbet Brandi, MD DMSc MHM
Role: PRINCIPAL_INVESTIGATOR
KNEA, Nordsjaellands Hospital
Locations
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Aarhus University Hospital - Site 43
Skejby, Aarhus N, Denmark
Odense University Hospital - Site 45
Odense, Odense C, Denmark
Rigshospitalet - Site 42
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Nordsjaellands Hospital - Site 41
Hillerød, , Denmark
Sjællands University Hospital Roskilde
Roskilde, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Identifier Type: -
Identifier Source: org_study_id
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