Clinical trial NCT01354405: Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
Official title: The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Liver Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2011-05-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ADPKD patients in Radboud University Hospital

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with ADPKD with polycystic liver (\> 20 liver cysts)
* 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:

* Kidney transplantation
* 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

Primary outcomes:
measure: Liver volume
timeFrame: 24 weeks
Secondary outcomes:
measure: Kidney volume
timeFrame: 24 weeks
measure: Glomerular filtration rate
timeFrame: 24 weeks
measure: Urinary tubular damage markers
timeFrame: 24 weeks
measure: Symptoms
timeFrame: 24 weeks
measure: Blood pressure
timeFrame: 24 weeks
measure: quality of life
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Hospital
state: Gelderland
Study officials:
affiliation: Radboud University Hospital
name: Joost PH Drenth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.