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Study · Randomized controlled trial · n = 48 · 2020

5 results

Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement: A Randomized Clinical Trial.

Hogan MC, Chamberlin JA, Vaughan LE, Waits AL, Banks C, Leistikow K, Oftsie T, Madsen C, Edwards M, Glockner J, Kremers WK, Harris PC and 4 more

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LaRusso NF, Torres VE, Torres VE, Masyuk TV

Clinical journal of the American Society of Nephrology : CJASN25 Aug 2020Cited by 32 (Europe PMC)

PMID32843370 (opens in a new tab)PMCIDPMC7480539 (opens in a new tab)DOI10.2215/cjn.13661119 (opens in a new tab)PepBankPUB-32843370
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In severe polycystic liver disease, annualized height-adjusted liver volume changed by -99±189 ml/m and -3%±7% with pasireotide (2582±1381 to 2479±1317 ml/m), versus 136±117 ml/m and 6%±7% with placebo (2387±759 to 2533±770 ml/m; P<0.001 for both).

    In plain wordsIn severe polycystic liver disease, liver volume decreased with pasireotide and increased with placebo.

    Peptide
    Pasireotide
    Outcome
    DecreaseHeight-adjusted total liver volume change
    Study

    n = 41

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 1 yearAs given in this study (human).

    Measurements

    Annualized absolute change in height-adjusted total liver volume
    −99 ml/m
    pasireotide LAR group; ±189
    Annualized percent change in height-adjusted total liver volume
    −3%
    pasireotide LAR group; ±7
    Annualized absolute change in height-adjusted total liver volume
    136 ml/m
    placebo group; ±117
    Annualized percent change in height-adjusted total liver volume
    6%
    placebo group; ±7
    Height-adjusted total liver volume at baseline
    2582 ml/m
    pasireotide LAR group; ±1381
    Height-adjusted total liver volume after treatment
    2479 ml/m
    pasireotide LAR group; ±1317
    Height-adjusted total liver volume at baseline
    2387 ml/m
    placebo group; ±759
    Height-adjusted total liver volume after treatment
    2533 ml/m
    placebo group; ±770

    1 more measurement in the study.

    Source sentences

    Summary
    From baseline, there were -99±189 ml/m absolute and -3%±7% change in annualized change in height-adjusted total liver volume (from 2582±1381 to 2479±1317 ml/m) in the pasireotide long-acting release group compared with 136±117 ml/m absolute and 6%±7% increase (from 2387±759 to 2533±770 ml/m) in plac…
    1 context sentence
    Summary · context
    Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In severe polycystic liver disease, kidney volumes decreased by 12±34 ml/m and 1%±4% with pasireotide versus increases of 21±21 ml/m and 4%±5% with placebo (P=0.05).

    In plain wordsIn these patients, kidney volume decreased with pasireotide and increased with placebo.

    Peptide
    Pasireotide
    Outcome
    DecreaseTotal kidney volume change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated · 1 yearAs given in this study (human).

    Measurements

    Change in total kidney volume
    −12 ml/m
    pasireotide LAR group; ±34
    Percent change in total kidney volume
    −1%
    pasireotide LAR group; ±4
    Change in total kidney volume
    21 ml/m
    placebo group; ±21
    Percent change in total kidney volume
    4%
    placebo group; ±5
    P value
    0.05
    absolute and percent change vs placebo

    Source sentences

    Summary
    Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21 ml/m and 4%±5% increase in the placebo group (P=0.05 for both).
    1 context sentence
    Summary · context
    Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In severe polycystic liver disease, eGFR changes were similar with pasireotide and placebo.

    In plain wordsIn these patients, kidney filtration changes were similar with pasireotide and placebo.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedeGFR change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Changes in eGFR were similar between groups.
    1 context sentence
    Summary · context
    Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo.
  4. 04HumanRandomized controlled trialSafety outcome

    In severe polycystic liver disease, hyperglycemia occurred in 26/33 (79%) pasireotide recipients versus 4/15 (27%) placebo recipients (P<0.001).

    In plain wordsIn these patients, high blood sugar occurred more often with pasireotide than placebo.

    Peptide
    Pasireotide
    Outcome
    IncreaseHyperglycemia
    Study

    n = 48

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 1 yearAs given in this study (human).

    Measurements

    Patients with hyperglycemia
    26 patients
    pasireotide LAR group, of 33
    Proportion with hyperglycemia
    79%
    pasireotide LAR group
    Patients with hyperglycemia
    4 patients
    placebo group, of 15
    Proportion with hyperglycemia
    27%
    placebo group
    P value
    < 0.001
    hyperglycemia vs placebo

    Source sentences

    Summary
    Among the n=48 randomized, adverse events included hyperglycemia (26 of 33 [79%] in pasireotide long-acting release versus four of 15 [27%] in the placebo group; P<0.001)
    1 context sentence
    Summary · context
    Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    Among patients without baseline diabetes, diabetes developed in 19/32 (59%) with pasireotide versus 1/15 (7%) with placebo (P=0.001).

    In plain wordsAmong patients without diabetes initially, diabetes developed more often with pasireotide than placebo.

    Peptide
    Pasireotide
    Outcome
    IncreaseNew diabetes
    Study

    n = 47

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 1 yearAs given in this study (human).

    Measurements

    Patients who developed diabetes
    19 patients
    pasireotide LAR group, of 32 without baseline diabetes
    Proportion who developed diabetes
    59%
    pasireotide LAR group
    Patients who developed diabetes
    1 patients
    placebo group, of 15 without baseline diabetes
    Proportion who developed diabetes
    7%
    placebo group
    P value
    0.001
    new diabetes vs placebo

    Source sentences

    Summary
    and among the 47 without diabetes at baseline, 19 of 32 (59%) in the pasireotide long-acting release group versus one of 15 (7%) in the placebo group developed diabetes (P=0.001).
    1 context sentence
    Summary · context
    Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01670110

Pasireotide LAR in Severe Polycystic Liver Disease

Mayo Clinicn = 48Aug 2012 to Sept 2018

Somatostatin Analogs · Polycystic Liver Disease · Autosomal Dominant Polycystic Kidney Disease · Autosomal Dominant Polycystic Liver Disease

Trial pageClinicalTrials.govUpdated 1 May 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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