Clinical Trial: Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease

Brief Summary: The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

Detailed Summary:

The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.

The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.


Sponsor: Radboud University

Current Primary Outcome: Liver volume [ Time Frame: 24 weeks ]

Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Kidney volume [ Time Frame: 24 weeks ]
    Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry
  • Glomerular filtration rate [ Time Frame: 24 weeks ]
    Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement
  • Urinary tubular damage markers [ Time Frame: 24 weeks ]
    Change in urinary tubular damage markers between baseline and 24 weeks
  • Symptoms [ Time Frame: 24 weeks ]
    Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire
  • Blood pressure [ Time Frame: 24 weeks ]
    Change in blood pressure between baseline and 24 weeks
  • quality of life [ Time Frame: 24 weeks ]
    Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire
  • Adverse events [ Time Frame: 24 weeks ]
    All adverse events that occur during 24 weeks of treatment


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: May 13, 2011
Date Started: May 2011
Date Completion:
Last Updated: July 8, 2014
Last Verified: July 2014