Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01354405
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536330', 'term': 'Polycystic liver disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060347', 'term': 'lanreotide'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-08', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-13', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver volume', 'timeFrame': '24 weeks', 'description': 'Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry'}], 'secondaryOutcomes': [{'measure': 'Kidney volume', 'timeFrame': '24 weeks', 'description': 'Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry'}, {'measure': 'Glomerular filtration rate', 'timeFrame': '24 weeks', 'description': 'Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement'}, {'measure': 'Urinary tubular damage markers', 'timeFrame': '24 weeks', 'description': 'Change in urinary tubular damage markers between baseline and 24 weeks'}, {'measure': 'Symptoms', 'timeFrame': '24 weeks', 'description': 'Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire'}, {'measure': 'Blood pressure', 'timeFrame': '24 weeks', 'description': 'Change in blood pressure between baseline and 24 weeks'}, {'measure': 'quality of life', 'timeFrame': '24 weeks', 'description': 'Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire'}, {'measure': 'Adverse events', 'timeFrame': '24 weeks', 'description': 'All adverse events that occur during 24 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycystic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '19646443', 'type': 'BACKGROUND', 'citation': 'van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.'}, {'pmid': '25369108', 'type': 'DERIVED', 'citation': 'Gevers TJ, Hol JC, Monshouwer R, Dekker HM, Wetzels JF, Drenth JP. Effect of lanreotide on polycystic liver and kidneys in autosomal dominant polycystic kidney disease: an observational trial. Liver Int. 2015 May;35(5):1607-14. doi: 10.1111/liv.12726. Epub 2014 Dec 1.'}, {'pmid': '22475206', 'type': 'DERIVED', 'citation': 'Gevers TJ, Chrispijn M, Wetzels JF, Drenth JP. Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease. BMC Nephrol. 2012 Apr 4;13:17. doi: 10.1186/1471-2369-13-17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.', 'detailedDescription': 'The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.\n\nThe investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ADPKD patients in Radboud University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ADPKD with polycystic liver (\\> 20 liver cysts)\n* Renal function MDRD \\>40 ml/hr\n* Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements\n\nExclusion Criteria:\n\n* Kidney transplantation\n* Renal failure requiring hemodialysis\n* Use of oral contraceptives or estrogen suppletion\n* Women who are pregnant or breastfeeding\n* History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc\n* Intervention (aspiration or surgical intervention) within three months from baseline\n* Treatment with somatostatin analogues within three months from baseline\n* Mental illness that interferes with the patient ability to comply with the protocol\n* Drug or alcohol abuse within one year from baseline\n* Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)\n* Clinical diagnosis of pancreatitis\n* Diagnosis of diabetes mellitus, as determined by blood test and medical history\n* Use of drugs that can interact with lanreotide, such as cyclosporin'}, 'identificationModule': {'nctId': 'NCT01354405', 'acronym': 'RESOLVE', 'briefTitle': 'Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': 'PCLD 10-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lanreotide', 'interventionNames': ['Drug: Lanreotide']}], 'interventions': [{'name': 'Lanreotide', 'type': 'DRUG', 'otherNames': ['Somatuline'], 'description': '120 mg every 28 days intramuscular', 'armGroupLabels': ['Lanreotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Joost PH Drenth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}