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

Completed

• Conditions: Polycystic Liver Disease
• Interventions: Drug: Lanreotide

• Registration Number: NCT01354405
• Lead Sponsor: Radboud University Medical Center

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 Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lanreotide	Lanreotide	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radboud University Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands