To investigate the effect of Lanreotide on renal function decline in ADPKD patients

• Conditions: First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume.; MedDRA version: 14.1Level: LLTClassification code 10023433Term: Kidney polycysticSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-005017-37-NL
• Lead Sponsor: DIPAK Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-21
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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 marketed) 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, with the exception of stable atrial fibrillation.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate whether Lanreotide modifies progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and kidney<br>volume growth.;Secondary Objective: To demonstrate whether Lanreotide modifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liver disease as measured by change in rate of liver volume growth.;Primary end point(s): Difference in change in renal function in lanreotide versus not treated patients, as assessed as slope through serial eGFR<br>measurements over time, with the value obtained at month 3 as first eGFR and the last eGFR available as last eGFR<br>measurement for slope analysis.;Timepoint(s) of evaluation of this end point: At the end of the study, when all patients have finished the protocol.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • change in renal volume (MRI),<br>• change in liver volume (MRI) in the subset of ADPKD patients with moderate tot severe polycystic liver disease<br>• quality of life (questionnaires)<br>• tolerability of Lanreotide;Timepoint(s) of evaluation of this end point: At the end of the study, when all patients have finished the protocol.