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

A randomised, controlled clinical trial assessing the efficacy of Lanreotide to halt disease progression in ADPKD - The DIPAK 1 Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005017-37-NL

Enrollment

300

Registered

2012-05-21

Start date

2012-05-30

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and change in renal volume. Second, 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 liver volume. MedDRA version: 14.1 Level: LLT Classification code 10023433 Term: Kidney polycystic System Organ Cla

Interventions

Trade Name: Somatuline Autogel Product Name: Lanreotide Product Code: BIM 23014 Pharmaceutical Form: Solution for injection INN or Proposed INN: Lanreotide CAS Number: 127984-74-1 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 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 measurements over time, with the value obtained at month 3 as first eGFR and the last eGFR available as last eGFR 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.	—

Measure

Time frame

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 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 measurements over time, with the value obtained at month 3 as first eGFR and the last eGFR available as last eGFR 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.

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Secondary

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

Countries

Netherlands

Contacts

Public ContactCoordinator

Dipak Consortium

esther.meijer@umcg.nl00310503614396

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026