NL-OMON39497
Completed
Phase 3
A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKD - The DIPAK 1 Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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.
Outcomes
Primary Outcomes
Not specified
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