Somatostatin Analogues as a Volume Reducing Treatment of... | NCT01354405

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

NCT01354405

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Jul 9, 2014Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Polycystic Liver Disease

Interventions

Lanreotide

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 13, 2011

First Submission Date that Met QC Criteria

May 13, 2011

First Posted Date

May 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2014

Last Update Posted Date

Jul 9, 2014Estimated

Name	Class
Ipsen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

43Actual

Label	Type	Description	Intervention Names
Lanreotide			Drug: Lanreotide

Name	Type	Description	Arm Group Labels	Other Names
Lanreotide	Drug	120 mg every 28 days intramuscular	Lanreotide	Somatuline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liver volume	Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Kidney volume	Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry	24 weeks
Glomerular filtration rate	Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

ADPKD patients in Radboud University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joost PH Drenth, MD, PhD	Radboud University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Hospital		Nijmegen	Gelderland	6500HB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19646443	Background	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.
25369108	Derived