NCT00565097

Brief Summary

To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

February 17, 2009

Status Verified

February 1, 2009

First QC Date

November 28, 2007

Last Update Submit

February 16, 2009

Conditions

Polycystic Liver DiseaseHepatomegalyLiver DiseasesPolycystic Kidney, Autosomal Dominant

Keywords

Polycystic Liver DiseaseAutosomal Dominant Polycystic Kidney DiseaseLiver cystLanreotide

Outcome Measures

Primary Outcomes (1)

  • Reduction of total liver volume as determined by CT scan

    6 months

Secondary Outcomes (3)

  • Reduction of liver volume and individual cyst volume on CT scan.

    6 months

  • Change of kidney volume and individual cyst volume on CT scan

    6 months

  • Symptom evaluation by (validated) questionnaires

    6 months

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

1

EXPERIMENTAL

Lanreotide

Drug: Lanreotide

Interventions

PlaceboDRUG
2
LanreotideDRUG
1

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs-of age
  • Multiple cysts \> 20
  • Cooperating patient
  • Is willing and able to comply with the study drug regimen and all other study requirements
  • Willingness to give written informed consent

You may not qualify if:

  • Use of oral anticonceptives or estrogen suppletion
  • Females who are pregnant or breast-feeding
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease
  • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Symptomatic gallstones
  • Renal failure requiring hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Gasthuisberg

Leuven, Belgium

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (1)

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PMID: 39356039DERIVED

MeSH Terms

Conditions

Polycystic liver diseaseHepatomegalyLiver DiseasesPolycystic Kidney, Autosomal Dominant

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Digestive System DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPolycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Joost PH Drenth, MD, PhD

    Radboud University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

  • Loes van Keimpema, MSc

    Radboud University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

  • Frederik Nevens, MD, PhD

    University Hospital Gasthuisberg, University of Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

October 1, 2007

Last Updated

February 17, 2009

Record last verified: 2009-02

Locations

NL(1)BE(1)