Skip to content

Trial · Observational

CompletedPhase not statedRegistry data

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

Short name RESOLVE

NCTNCT01354405 (opens ClinicalTrials.gov in a new tab)Other idPCLD 10-03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
43 participants (actual)
Sponsor
Radboud University Medical Center · Other
Design
Not stated
Countries
1 country

Netherlands

Start
May 2011
Primary completion
Jun 2014
Completion
Jun 2014
First posted
16 May 2011 (estimated)
Last update posted
9 Jul 2014 (estimated)
Conditions
Polycystic Liver Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph –

    RESOLVE

    NCT01354405

    May 2011 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LanreotideDrug

Arms1

  • Other

    Lanreotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Liver volume

    Time frame · 24 weeks

    Registry description

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

Secondary outcomes(7)

  1. Kidney volume

    Time frame · 24 weeks

    Registry description

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

  2. Glomerular filtration rate

    Time frame · 24 weeks

    Registry description

    Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement

  3. Urinary tubular damage markers

    Time frame · 24 weeks

    Registry description

    Change in urinary tubular damage markers between baseline and 24 weeks

  4. Symptoms

    Time frame · 24 weeks

    Registry description

    Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire

  5. Blood pressure

    Time frame · 24 weeks

    Registry description

    Change in blood pressure between baseline and 24 weeks

  6. quality of life

    Time frame · 24 weeks

    Registry description

    Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire

  7. Adverse events

    Time frame · 24 weeks

    Registry description

    All adverse events that occur during 24 weeks of treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

4 results

Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.

van Keimpema et al. 2009Gastroenterologycited by 176

PMID 19646443DOI 10.1053/j.gastro.2009.07.052PUB-19646443

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

2 studies on this page

Indexing hint: Observational study · 2015

Effect of lanreotide on polycystic liver and kidneys in autosomal dominant polycystic kidney disease: an observational trial.

Gevers et al. 2015Liver international : official journal of the International Association for the Study of the Livercited by 34

PMID 25369108DOI 10.1111/liv.12726PUB-25369108

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 2012

Rationale and design of the RESOLVE trial: lanreotide as a volume reducing treatment for polycystic livers in patients with autosomal dominant polycystic kidney disease.

Gevers et al. 2012BMC nephrologycited by 9

PMID 22475206PMC3368739DOI 10.1186/1471-2369-13-17PUB-22475206

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.