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

Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Liver volume

Secondary Outcome

 Kidney volume

Condition

Polycystic Liver Disease

Intervention

Lanreotide

Study Arms / Comparison Groups

 Lanreotide
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

May 2011

Completion Date

June 2014

Primary Completion Date

June 2014

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Joost PH Drenth, MD, PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT01354405

Organization ID

PCLD 10-03


Responsible Party

Sponsor

Study Sponsor

Radboud University Medical Center

Collaborators

 Ipsen

Study Sponsor

Joost PH Drenth, MD, PhD, Principal Investigator, Radboud University Hospital


Verification Date

July 2014