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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01354405
Collaborator
Ipsen (Industry)
43
Enrollment
1
Location
37
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Lanreotide

Drug: Lanreotide
120 mg every 28 days intramuscular
Other Names:
  • Somatuline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liver volume [24 weeks]

      Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry

    Secondary Outcome Measures

    1. Kidney volume [24 weeks]

      Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry

    2. Glomerular filtration rate [24 weeks]

      Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement

    3. Urinary tubular damage markers [24 weeks]

      Change in urinary tubular damage markers between baseline and 24 weeks

    4. Symptoms [24 weeks]

      Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire

    5. Blood pressure [24 weeks]

      Change in blood pressure between baseline and 24 weeks

    6. quality of life [24 weeks]

      Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire

    7. Adverse events [24 weeks]

      All adverse events that occur during 24 weeks of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Hospital Nijmegen Gelderland Netherlands 6500HB

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Ipsen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01354405
    Other Study ID Numbers:
    • PCLD 10-03
    First Posted:
    May 16, 2011
    Last Update Posted:
    Jul 9, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Liver Diseases
    Lanreotide

    Study Results

    No Results Posted as of Jul 9, 2014