Polycystic Liver DiseaseRESOLVENCT01354405
Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
An observational study of Polycystic Liver Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polycystic Liver Disease
- What is being tested?
- Lanreotide
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ADPKD patients in Radboud University Hospital
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Hospital
Nijmegen, Gelderland, 6500HB
About this study
Official title: The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
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.
Read the 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.
- Conditions
- Polycystic Liver Disease
- Being tested
- Lanreotide
- Medical subject headings
- Polycystic liver disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanreotideDrug
Also called Somatuline
120 mg every 28 days intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide | Not described Receives: Drug: Lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver volume
Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry
Measured: 24 weeks
Secondary outcomes (7)
Kidney volume
Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry
Measured: 24 weeks
Glomerular filtration rate
Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement
Measured: 24 weeks
Urinary tubular damage markers
Change in urinary tubular damage markers between baseline and 24 weeks
Measured: 24 weeks
Symptoms
Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire
Measured: 24 weeks
Blood pressure
Change in blood pressure between baseline and 24 weeks
Measured: 24 weeks
quality of life
Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire
Measured: 24 weeks
Adverse events
All adverse events that occur during 24 weeks of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Joost PH Drenth, MD, PhD, Principal investigator, Radboud University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354405
- Sponsor's protocol ID
- PCLD 10-03
- Acronym
- RESOLVE
- Status last verified
- Jul 2014
- First submitted
- 13 May 2011
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19646443Gevers 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.
PubMed 25369108Gevers 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.
PubMed 22475206
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT01354405
- Acronym / sponsor ID
- RESOLVE / PCLD 10-03
- Conditions
- Polycystic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanreotide | – | Drug: Lanreotide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ADPKD patients in Radboud University Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LanreotideAlso: Somatuline120 mg every 28 days intramuscular | Drug | Lanreotide |
Primary outcome
Liver volume
Time frame: 24 weeks
Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry
7 secondary outcomes
Kidney volume
Time frame: 24 weeks
Glomerular filtration rate
Time frame: 24 weeks
Urinary tubular damage markers
Time frame: 24 weeks
Symptoms
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
quality of life
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Background: PubMed 19646443van 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.
- Derived from this study: PubMed 25369108Gevers 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.
- Derived from this study: PubMed 22475206Gevers 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.
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Polycystic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost PH Drenth, MD, PhD principal investigator
Radboud University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Liver Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver volume (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354405, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.