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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Polycystic Liver Disease

Intervention / Treatment
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* Drug: Lanreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ADPKD with polycystic liver (> 20 liver cysts) Renal function MDRD >40 ml/hr Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements Exclusion Criteria: Kidney transplantation Renal failure requiring hemodialysis Use of oral contraceptives or estrogen suppletion Women who are pregnant or breastfeeding History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc Intervention (aspiration or surgical intervention) within three months from baseline Treatment with somatostatin analogues within three months from baseline Mental illness that interferes with the patient ability to comply with the protocol Drug or alcohol abuse within one year from baseline Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD) Clinical diagnosis of pancreatitis Diagnosis of diabetes mellitus, as determined by blood test and medical history Use of drugs that can interact with lanreotide, such as cyclosporin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lanreotide<br> | Drug: Lanreotide<br>* 120 mg every 28 days intramuscular<br>* Other names: Somatuline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver volume | Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry | 24 weeks | 

Secondary Outcome Measures

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