A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKD

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

1. Diagnosis of ADPKD, based upon the modified Ravine criteria;2. Age between 18 and 60 years.;3. eGFR (MDRD) between 30 and 60 mL/min/1.73 m2.;4. Providing informed consent.

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. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. nephrotoxic medications such as chronic NSAID, cyclosporine, lithium immunosuppressant use, and e.g. diabetes mellitus requiring medication 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., not approved by FDA/EMA for indication of ADPKD) therapies.;6. Patients having used Lanreotide (or another somatostatin analogue) in the 3 months before study start.;7. Patients known with 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 arrhythmia*s, that are considerd dangerous in combination with lanreotide.;11. Patients, who ever suffered from symptomatic gallstones, with the exception of patients who underwent a cholecystectomy.;12. Patients, who have a medical history of pancreatitis.;13. Patients, who have a medical history of infected liver cysts.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in change in renal function in lanreotide versus not treated<br /><br>patients, as assessed as slope through serial eGFR measurements over time, with<br /><br>the value obtained at month 3 as first eGFR and the last eGFR available as last<br /><br>eGFR measurement for slope analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• change in renal volume (MRI),<br /><br>• change in liver volume (MRI) in the subset of ADPKD patients with moderate<br /><br>tot severe polycystic liver disease<br /><br>• quality of life (questionnaires)<br /><br>• tolerability of Lanreotide</p><br>