Open-label, Extension Study of Oral Tolvaptan Tablet Regimens in ADPKD

• Research type

  Research Study

• Full title

  Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• IRAS ID

  47817

• Contact name

  Iain MacPhee

• Sponsor organisation

  Otsuka Pharmaceutical Development & Commercialization, Inc

• Eudract number

  2010-018401-10

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disorder characterised by the formation oflud-filled cysts in the kidneys. The accumulation of these cysts enlarges the kidneys, impairing renal function and may lead to renal failure requiring dialysis or transplantation. This disease can be life-threatening. Aside from early antihypertensive control and dietary protein restriction, which may offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality. Tolvaptan is an oral vasopressin (water regulating hormone) inhibitor acting principally at the kidney cells affected by ADPKD. A rationale for use of tolvaptan in ADPKD is supported by research conducted in a variety of animal models. In these models, tolvaptan is effective in halting or reversing the progression of this renal disease. This study is designed to assess the long term safety of tolvaptan and the continued effects of tolvaptan on the progression of ADPKD in patients completing prior clinical trials with tolvaptan in ADPKD. Tolvaptan will be self-administered by the patient for a minimum of 24 months and up to 60 months. Treatment visits will occur at Months 1, 3 and 6, and every 6 months thereafter. During these visits participants will undergo a number of assessments including vital signs, physical examination and blood tests. The study will be conducted at approximately 130 centres globally and at 11 centres within the UK.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/30

• Date of REC Opinion

  5 Oct 2010

• REC opinion

  Further Information Favourable Opinion