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Polycystic Liver DiseasePhase 2ELATENCT01157858

Everolimus and LongActing Octreotide Trial in Polycystic Livers

A Phase 2 study testing Everolimus and Octreotide LAR in people with Polycystic Liver Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy. 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?
Everolimus and Octreotide LAR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteNetherlands
Study dates
Jun 2010to Jul 2012
Phase
Phase 2
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

Who may be able to join

  • 18 < age ≤ 70 years
  • Polycystic liver disease (PCLD), defined as ≥ 20 liver cysts
  • Total liver volume must be at least 2500 mL
  • Symptomatic defined as ECOG-PS ≥ 1 (see fig 3.1)38, and having at least three out of ten PCLD symptoms:
  • Abdominal pain
  • Abdominal distension
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  • Abdominal fullness
  • Dyspnea
  • Early satiety
  • Back pain
  • Nausea/vomiting
  • Anorexia
  • Weight loss
  • Jaundice
  • Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements

Who cannot join

  • ADPKD patients
  • Use of oral anticonceptives or estrogen supplementation
  • Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the administration of study medication.
  • Intervention (aspiration or surgical intervention) within three months before baseline
  • Treatment with somatostatin analogues within three months before baseline
  • Patients with a kidney transplant
Show all 23Show fewer
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
  • 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 (octreotide decreases gall bladder volume)
  • Hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy
  • Granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
  • Infection with hepatitis B, hepatitis C, HIV, TBC (in medical history)
  • Mental illness that interferes with the patient ability to comply with the protocol
  • Drug or alcohol abuse within one year of baseline
  • Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin
  • Known hypersensitivity to everolimus or one of its excipients
  • Enrolment in another clinical trial of an investigational agent while participating in this study
  • Moderate or severe reaction on contrast in medical history
  • Treatment with I131 during the course of the trial
  • Use of metformin
  • Morbus Kahler or Morbus Waldenstrom with excretion of light chains in urine in medical history
  • Kidney dysfunction (MDRD-GFR < 60 ml/min/1.73m2 and ECC < 60 ml/min, calculated by the Cockcroft-Gault formula); in case of decreased body muscle mass, exact ECC is measured using serum and urine creatinine

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

Official title: Everolimus Added to Long Acting Octreotide as a Volume Reducing Treatment of Polycystic Livers

The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy.

Read the detailed description

This is a single center randomized, open-label, parallel study comparing the safety and efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult symptomatic patients with polycystic livers because of polycystic liver disease (PCLD).

We aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients in the combination group and 22 patients in the mono therapy group.The duration of the trial will be 52 weeks. The treatment will be 48 weeks and the last control visit will take place four weeks after the treatment.

Being tested
Everolimus, Octreotide LAR
Keywords
liver cyst
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.

  • EverolimusDrug

    Also called Afinitor

    2.5 mg every day orally

  • Octreotide LARDrug

    Also called Sandostatine LAR

    40 mg every 28 days IM

Study groups in NCT01157858
Study groupRoleWhat they receive
Everolimus + octreotide LARActive comparatorOctreotide LAR combined with everolimus
Receives: Drug: Everolimus; Drug: Octreotide LAR
Octreotide LARActive comparatorOctreotide LAR monotherapy
Receives: Drug: Octreotide LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver volume

    change of total liver volume in terms of percentage from baseline to 12 months as determined by CT

    Measured: at baseline and at 12 months

Secondary outcomes (4)

  1. Symptoms

    Change in symptoms, measured by GI-questionnaire

    Measured: baseline and 12 months

  2. Quality of Life

    Change in quality of life, measured by EuroQoL-questionnaire

    Measured: baseline and 12 months

  3. Responders

    Proportion of patients having any reduction in total liver volume after 12 months

    Measured: baseline and 12 months

  4. Adverse events

    Adverse events that occur in these 12 months

    Measured: During 12 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01157858
Sponsor's protocol ID
CSMS995 ANLIIT
Acronym
ELATE
Status last verified
Jun 2015
First submitted
6 Jul 2010
Last updated
29 Jun 2015
Results posted
No
Data monitoring committee
Yes

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

  • Chrispijn M, Drenth JP. Everolimus and long acting octreotide as a volume reducing treatment of polycystic livers (ELATE): study protocol for a randomized controlled trial. Trials. 2011 Nov 21;12:246. doi: 10.1186/1745-6215-12-246.

    PubMed 22104015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and Octreotide LAR in people with 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 15 inclusion and 23 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 29 Jun 2015. 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.

What does this 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.

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?

Liver volume (time frame: at baseline and at 12 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 NCT01157858, which also lists 2 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 29 Jun 2015.

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