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

18 Years
70 Years
Open (Enrolling)
Polycystic Liver Disease

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Liver volume

Outcome Description:

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

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Joost PH Drenth, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Hospital


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

PCLD 10-03



Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Polycystic Liver Disease
  • Polycystic Kidney Diseases
  • Liver Diseases
  • Polycystic Kidney, Autosomal Dominant
  • Cysts