Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
NCT ID: NCT01354405
Last Updated: 2014-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2011-05-31
2014-06-30
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lanreotide
Lanreotide
120 mg every 28 days intramuscular
Interventions
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Lanreotide
120 mg every 28 days intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Renal function MDRD \>40 ml/hr
* Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Exclusion Criteria
* Renal failure requiring hemodialysis
* Use of oral contraceptives or estrogen suppletion
* Women who are pregnant or breastfeeding
* History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc
* Intervention (aspiration or surgical intervention) within three months from baseline
* Treatment with somatostatin analogues within three months from baseline
* Mental illness that interferes with the patient ability to comply with the protocol
* Drug or alcohol abuse within one year from baseline
* Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)
* Clinical diagnosis of pancreatitis
* Diagnosis of diabetes mellitus, as determined by blood test and medical history
* Use of drugs that can interact with lanreotide, such as cyclosporin
18 Years
70 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joost PH Drenth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Hospital
Locations
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Radboud University Hospital
Nijmegen, Gelderland, Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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PCLD 10-03
Identifier Type: -
Identifier Source: org_study_id
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