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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01354405
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : July 9, 2014
Information provided by (Responsible Party):
Radboud University

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
Polycystic Liver Disease 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.

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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 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
Lanreotide Drug: Lanreotide
120 mg every 28 days intramuscular
Other Name: Somatuline

Primary Outcome Measures :
  1. Liver volume [ Time Frame: 24 weeks ]
    Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry

Secondary Outcome Measures :
  1. Kidney volume [ Time Frame: 24 weeks ]
    Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry

  2. Glomerular filtration rate [ Time Frame: 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 [ Time Frame: 24 weeks ]
    Change in urinary tubular damage markers between baseline and 24 weeks

  4. Symptoms [ Time Frame: 24 weeks ]
    Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire

  5. Blood pressure [ Time Frame: 24 weeks ]
    Change in blood pressure between baseline and 24 weeks

  6. quality of life [ Time Frame: 24 weeks ]
    Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire

  7. Adverse events [ Time Frame: 24 weeks ]
    All adverse events that occur during 24 weeks of treatment

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ADPKD patients in Radboud University Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01354405

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Radboud University Hospital
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: Joost PH Drenth, MD, PhD Radboud University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Radboud University Identifier: NCT01354405    
Other Study ID Numbers: PCLD 10-03
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs