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

Radboud University Medical Center

Status: Completed

Conditions: Polycystic Liver Disease

Treatments: Drug: Lanreotide

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01354405

PCLD 10-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)
• 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

Trial design

43 participants in 1 patient group

Lanreotide

Treatment:

Drug: Lanreotide