Study of Lanreotide to Treat Polycystic Kidney Disease

Exclusion Criteria

• •1. Patients who, in the opinion of the study investigator may present a safety risk.
• •2. Patients who are unlikely to adequately comply with the trial's procedures \[due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
• •3. a. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. nephrotoxic medications such as chronic NSAID, cyclosporine, lithium immunosuppressant use) b. Patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed and patients with proteinuria \> 1 g /24hr).
• •4. Patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry or are likely candidates for these procedures within 2 years of start of the study.
• •5. Patients taking other experimental (i.e.,non approved by FDA/EMA or indication of ADPKD) therapies.
• •6. Patients having used Lanreotide (or another somatostatin analogue) in the 3 months before study start.
• •7. Patients with known intolerance for Lanreotide (or another somatostatin analogue).
• •8. Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational product.
• •9. Women, who are pregnant or breastfeeding.
• •10. Patients, who suffer from cardiac arrhythmias, that are thought to be dangerous in combination with lanreotide administration.
• •11. Patients, who ever suffered from symptomatic gallstones and did not undergo cholecystectomy.
• •12. Patients, who have a medical history of pancreatitis.
• •13. Patients, who have a medical history of infected liver cysts.
• •In addition:
• •Patients, who underwent liver cyst drainage or surgery in the year before, can enter the study, but will not be assessed for change in liver volume.
• •Patients having contraindications to, or interference with MRI assessments, as dictated by local regulation, will not be allowed to undergo MR imaging. However, these patients can enter the study, but will not be assessed for change in kidney and/or liver volume.