Polycystic Liver DiseasePhase 2/3LOCKCYSTNCT00565097
Lanreotide as Treatment of Polycystic Livers
A Phase 2/3 study testing Lanreotide in people with Polycystic Liver Disease and Hepatomegaly, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases
- What is being tested?
- Lanreotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2007to not given
- Phase
- Phase 2/3
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
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.
- Conditions
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
- Being tested
- Placebo, Lanreotide
- Keywords
- Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Liver cyst, Lanreotide
- Medical subject headings
- Polycystic liver disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
LanreotideDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 1 | Experimental | Lanreotide Receives: Drug: Lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total liver volume as determined by CT scan
Measured: 6 months
Secondary outcomes (3)
Reduction of liver volume and individual cyst volume on CT scan.
Measured: 6 months
Change of kidney volume and individual cyst volume on CT scan
Measured: 6 months
Symptom evaluation by (validated) questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Investigators
- Joost PH Drenth, MD, PhD, Principal investigator, Radboud University Medical Center NijmegenLoes van Keimpema, MSc, Principal investigator, Radboud University Medical Center NijmegenFrederik Nevens, MD, PhD, Principal investigator, University Hospital Gasthuisberg, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565097
- Sponsor's protocol ID
- CMO 2007/010;ABR NL16194.091.0
- Acronym
- LOCKCYST
- Status last verified
- Feb 2009
- First submitted
- 28 Nov 2007
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
- ClinicalTrials.gov ID
- NCT00565097
- Acronym / sponsor ID
- LOCKCYST / CMO 2007/010;ABR NL16194.091.0
- Conditions
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
- Keywords
- Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Liver cyst, Lanreotide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Oct 2007
- First posted
- 29 Nov 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
| 1 | Experimental | Drug: LanreotideLanreotide |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Placebo | Drug | 2 |
| Lanreotide | Drug | 1 |
Primary outcome
Reduction of total liver volume as determined by CT scan
Time frame: 6 months
3 secondary outcomes
Reduction of liver volume and individual cyst volume on CT scan.
Time frame: 6 months
Change of kidney volume and individual cyst volume on CT scan
Time frame: 6 months
Symptom evaluation by (validated) questionnaires
Time frame: 6 months
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 17 Feb 2009.
- Derived from this study: PubMed 39356039St 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.
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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 Medical Center Nijmegen
Loes van Keimpema, MSc principal investigator
Radboud University Medical Center Nijmegen
Frederik Nevens, MD, PhD principal investigator
University Hospital Gasthuisberg, University of Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lanreotide in people with Polycystic Liver Disease and Hepatomegaly, run by Radboud University Medical Center at 2 sites in 2 countries.
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 5 inclusion and 7 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 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of total liver volume as determined by CT scan (time frame: 6 months). 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 NCT00565097, which also lists 1 linked publication.
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 17 Feb 2009.