Polycystic Liver Disease
Conditions
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.
Interventions
DRUGLanreotide
120 mg every 28 days intramuscular
Sponsors
Ipsen
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver volume | 24 weeks | Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular filtration rate | 24 weeks | Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement |
| Urinary tubular damage markers | 24 weeks | Change in urinary tubular damage markers between baseline and 24 weeks |
| 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 |
| Adverse events | 24 weeks | All adverse events that occur during 24 weeks of treatment |
| Blood pressure | 24 weeks | Change in blood pressure between baseline and 24 weeks |
Countries
Netherlands
Outcome results
None listed