EUCTR2011-005017-37-NL
Active, not recruiting
Not Applicable
A randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study
DIPAK Consortium0 sitesMay 21, 2012
ConditionsFirst, 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 disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsSomatuline Autogel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- DIPAK Consortium
- Status
- Active, not recruiting
- Last Updated
- 13 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.
- •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.
Outcomes
Primary Outcomes
Not specified
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