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Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE) | Clinical Trials | Clareo Health

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

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

NCT01354405•Radboud University Medical Center

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

Locations (1)

Radboud University Hospital

Nijmegen, Gelderland, Netherlands

Key Dates

Start Date

May 1, 2011

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

July 9, 2014

Enrollment

ACTUAL participants

Conditions

Polycystic Liver Disease

Interventions

Lanreotide

DRUG

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

NCT05478083

Polycystic Liver DiseaseAutosomal Dominant Polycystic Kidney

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UNKNOWN

The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

NCT05215964

Polycystic Kidney DiseasesPolycystic Liver Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease