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

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Liver Disease
• Intervention / Treatment: Drug: Lanreotide

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboud University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ADPKD patients in Radboud University Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lanreotide	Drug: Lanreotide; 120 mg every 28 days intramuscular; Other Names: Somatuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver volume	Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney volume	Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks
Glomerular filtration rate	Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement	24 weeks
Urinary tubular damage markers	Change in urinary tubular damage markers between baseline and 24 weeks	24 weeks
Symptoms	Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire	24 weeks
Blood pressure	Change in blood pressure between baseline and 24 weeks	24 weeks
quality of life	Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire	24 weeks
Adverse events	All adverse events that occur during 24 weeks of treatment	24 weeks

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Ipsen
• Investigators: Principal Investigator: Joost PH Drenth, MD, PhD, Radboud University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Antineoplastic Agents; Lanreotide
• Other Study ID Numbers: PCLD 10-03