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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

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