Autosomal Dominant Polycystic Kidney Clinical Trial
Official title:
Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease
Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open,
Blinded Endpoint (PROBE) design.
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.
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic kidney
disease and the fourth leading cause of end-stage renal disease in adults Worldwide.
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.
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