NCT01354405

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

3.1 years

First QC Date

May 13, 2011

Last Update Submit

July 8, 2014

Conditions

Polycystic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Liver volume

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

    24 weeks

Secondary Outcomes (7)

  • Kidney volume

    24 weeks

  • Glomerular filtration rate

    24 weeks

  • Urinary tubular damage markers

    24 weeks

  • Symptoms

    24 weeks

  • Blood pressure

    24 weeks

  • +2 more secondary outcomes

Study Arms (1)

Lanreotide

Drug: Lanreotide

Interventions

LanreotideDRUG

120 mg every 28 days intramuscular

Also known as: Somatuline
Lanreotide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ADPKD patients in Radboud University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Hospital

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (3)

  • van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.

    PMID: 19646443BACKGROUND

  • Gevers TJ, Hol JC, Monshouwer R, Dekker HM, Wetzels JF, Drenth JP. Effect of lanreotide on polycystic liver and kidneys in autosomal dominant polycystic kidney disease: an observational trial. Liver Int. 2015 May;35(5):1607-14. doi: 10.1111/liv.12726. Epub 2014 Dec 1.

    PMID: 25369108DERIVED

  • Gevers TJ, Chrispijn M, Wetzels JF, Drenth JP. Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease. BMC Nephrol. 2012 Apr 4;13:17. doi: 10.1186/1471-2369-13-17.

    PMID: 22475206DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Polycystic liver disease

Interventions

lanreotide

Study Officials

  • Joost PH Drenth, MD, PhD

    Radboud University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

NL(1)