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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Octreotide in Severe Polycystic Liver Disease

NCTNCT00426153 (opens ClinicalTrials.gov in a new tab)Other id06-004128Other idUL1RR024150
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
42 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jan 2007
Primary completion
Oct 2008
Completion
Oct 2008
First posted
24 Jan 2007 (estimated)
Last update posted
21 Nov 2012 (estimated)
Conditions
Polycystic Kidney, Autosomal Dominant · Polycystic Liver Disease · Hepatomegaly · Liver Diseases · Kidney, Polycystic · Abdominal Pain

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2/3

    Octreotide in Severe Polycystic Liver Disease

    NCT00426153

    Jan 2007 to Oct 2008

Registry summary

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

This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.

Interventions

  • OctreotideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Octreotide

    Participants received Octreotide LAR® Depot injections (up to 40 mg) intramuscularly every 28 days (+/- 5 days) for one year

  • Placebo comparator

    Placebo

    Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Liver Volume

    Time frame · Baseline, 12 months

    Registry description

    Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans

Secondary outcomes(3)

  1. Percent Change in Renal Volume

    Time frame · Baseline, 12 months

    Registry description

    Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans

  2. Percent Change in Glomerular Filtration Rate (GFR)

    Time frame · Baseline, 12 months

    Registry description

    Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound

  3. Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores

    Time frame · Baseline, 12 months

    Registry description

    Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

Posted results

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

Primary outcome results

Primary outcomeMean· Baseline, 12 months

Percent Change in Liver Volume

GroupValue (percent change)Spread
Octreotide-5.06.77
Placebo0.98.33
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline, 12 months

Percent Change in Renal Volume

GroupValue (percent change)Spread
Octreotide0.257.53
Placebo8.6110.07
Secondary outcomeMean· Baseline, 12 months

Percent Change in Glomerular Filtration Rate (GFR)

GroupValue (percent change)Spread
Octreotide-5.115.46
Placebo-7.213.21
Secondary outcomeMean· Baseline, 12 months

Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores

GroupValue (units on a scale)Spread
Octreotide74.821.96
Placebo80.423.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OctreotideParticipants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year–3 / 2821 / 28
PlaceboParticipants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year–0 / 144 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2015

Efficacy of 4 Years of Octreotide Long-Acting Release Therapy in Patients With Severe Polycystic Liver Disease.

Hogan et al. 2015Mayo Clinic proceedingscited by 32

PMID 26166166PMC4928579DOI 10.1016/j.mayocp.2015.05.011PUB-26166166

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHogan MC, Masyuk TV, Page L, Holmes DR 3rd, Li X, Bergstralh EJ, Irazabal MV, Kim B, King BF, Glockner JF, Larusso NF, Torres VE. Somatostatin analog therapy for severe polycystic liver disease: results after 2 years. Nephrol Dial Transplant. 2012 Sep;27(9):3532-9. doi: 10.1093/ndt/gfs152. Epub 2012 Jul 6. PMID 22773240
  • DerivedSt 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. PMID 39356039

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age - 18 years and older * Diagnosis of Polycystic Liver Disease (PLD) associated with ADPKD or isolated Autosomal Dominant Polycystic liver Disease (ADPLD) * Severe PLD defined as a liver volume greater than 4000 mL or symptomatic disease due to mass effects from hepatic cysts * Not a candidate for or declining surgical intervention Exclusion Criteria: * Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception * Creatinine greater than 3mg/dL or hemodialysis dependent * Cancer or major systemic disease that could prevent completion of the planned follow-up or interfere with data collection or interpretation * Uncontrolled diabetes mellitus as defined by blood glucose levels of greater than or equal to 250 mg/dL on 2 or more consecutive daily readings despite antidiabetic therapy * Neurologic/psychologic conditions preventing appropriate informed consent * Symptomatic gallstones or biliary sludge * Variceal bleeding or hepatic encephalopathy within prior 30 days * Uncontrolled hypertension (Systolic blood pressure greater than 160 mmHg; Diastolic blood pressure greater than 100 mmHg) * Current, or prior use of somatostatin analogue (octreotide, lanreotide) in past 6 months * History of significant adverse reaction to a somatostatin analogue

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