Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

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Brief Title

Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

Official Title

Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in total Kidney Volume (tKV) measured by MRI scanning

Secondary Outcome

 Changes in GFR

Condition

Autosomal Dominant Polycystic Kidney

Intervention

Tolvaptan

Study Arms / Comparison Groups

 Tolvaptan group
Description:  Treatment with tolvaptan for six weeks followed by six weeks observation without trial medication

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

90

Start Date

September 12, 2018

Completion Date

April 2020

Primary Completion Date

June 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients 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-EPI formula of above or equal to 45 mL/min/1.73 m2

        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-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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Lisbet Brandi, MD DMSc MHM, +45 48295993, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03596957

Organization ID

PoCKET


Responsible Party

Sponsor-Investigator

Study Sponsor

Lisbet Brandi


Study Sponsor

Lisbet Brandi, MD DMSc MHM, Principal Investigator, KNEA, Nordsjaellands Hospital


Verification Date

November 2018