Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

Polycystic Liver Disease Clinical Trial

— RESOLVE  

Official title:

The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354405
• Other study ID #: PCLD 10-03
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: July 8, 2014
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cysts
• Liver Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant
• Polycystic Liver Disease

Intervention

Drug:
• Lanreotide
120 mg every 28 days intramuscular

Locations

Country	Name	City	State
Netherlands	Radboud University Hospital	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Ipsen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver volume	Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks	No
Secondary	Kidney volume	Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks	No
Secondary	Glomerular filtration rate	Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement	24 weeks	No
Secondary	Urinary tubular damage markers	Change in urinary tubular damage markers between baseline and 24 weeks	24 weeks	No
Secondary	Symptoms	Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire	24 weeks	No
Secondary	Blood pressure	Change in blood pressure between baseline and 24 weeks	24 weeks	No
Secondary	quality of life	Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire	24 weeks	No
Secondary	Adverse events	All adverse events that occur during 24 weeks of treatment	24 weeks	Yes

External Links

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