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Effects of Somatostatin on Liver in ADPKD

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
octeotride
placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of autosomal dominant polycystic kidney and liver disease
  • glomerular filtration rate greater than 40 ml/min

Exclusion Criteria:

  • diabetes mellitus
  • proteinuria greater than 1 g/24 hours
  • significant glomerular disease
  • urinary tract lithiasis and infections
  • symptomatic gallstones
  • biliary sludge
  • cancer
  • pregnant women
  • lactanting women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    OCTEOTRIDE

    Placebo

    Arm Description

    octeotride 20 mg, intramuscular injection monthly for 3 years

    Placebo (saline soluction), intramuscular injection monthly for 3 years

    Outcomes

    Primary Outcome Measures

    Effect of somatostatin on liver volume

    Secondary Outcome Measures

    Full Information

    First Posted
    April 17, 2014
    Last Updated
    April 18, 2014
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02119052
    Brief Title
    Effects of Somatostatin on Liver in ADPKD
    Official Title
    Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide. 35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autosomal Dominant Polycystic Kidney Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OCTEOTRIDE
    Arm Type
    Experimental
    Arm Description
    octeotride 20 mg, intramuscular injection monthly for 3 years
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (saline soluction), intramuscular injection monthly for 3 years
    Intervention Type
    Drug
    Intervention Name(s)
    octeotride
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Effect of somatostatin on liver volume
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of autosomal dominant polycystic kidney and liver disease glomerular filtration rate greater than 40 ml/min Exclusion Criteria: diabetes mellitus proteinuria greater than 1 g/24 hours significant glomerular disease urinary tract lithiasis and infections symptomatic gallstones biliary sludge cancer pregnant women lactanting women

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26844873
    Citation
    Pisani A, Sabbatini M, Imbriaco M, Riccio E, Rubis N, Prinster A, Perna A, Liuzzi R, Spinelli L, Santangelo M, Remuzzi G, Ruggenenti P; ALADIN Study Group. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030.e4. doi: 10.1016/j.cgh.2015.12.049. Epub 2016 Feb 1.
    Results Reference
    derived

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    Effects of Somatostatin on Liver in ADPKD

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