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

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01354405
First received: May 13, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Polycystic Liver Disease
Drug: Lanreotide

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Liver volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry


Secondary Outcome Measures:
  • Kidney volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry

  • Glomerular filtration rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement

  • Urinary tubular damage markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in urinary tubular damage markers between baseline and 24 weeks

  • Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire

  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure between baseline and 24 weeks

  • quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire

  • Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    All adverse events that occur during 24 weeks of treatment


Biospecimen Retention:   Samples With DNA

Blood samples


Enrollment: 43
Study Start Date: May 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lanreotide Drug: Lanreotide
120 mg every 28 days intramuscular
Other Name: Somatuline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ADPKD patients in Radboud University Hospital

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354405

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01354405     History of Changes
Other Study ID Numbers: PCLD 10-03
Study First Received: May 13, 2011
Last Updated: July 8, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Polycystic Kidney Diseases
Liver Diseases
Polycystic Kidney, Autosomal Dominant
Cysts
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014