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Original ArticlesCystic Kidney Disease
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Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement

A Randomized Clinical Trial

Marie C. Hogan, Julie A. Chamberlin, Lisa E. Vaughan, Angela L. Waits, Carly Banks, Kathleen Leistikow, Troy Oftsie, Chuck Madsen, Marie Edwards, James Glockner, Walter K. Kremers, Peter C. Harris, Nicholas F. LaRusso, Vicente E. Torres and Tatyana V. Masyuk
CJASN September 2020, 15 (9) 1267-1278; DOI: https://doi.org/10.2215/CJN.13661119
Marie C. Hogan
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Julie A. Chamberlin
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Lisa E. Vaughan
2Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota
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Angela L. Waits
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Carly Banks
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Kathleen Leistikow
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Troy Oftsie
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Chuck Madsen
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Marie Edwards
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
3Biomedical Imaging Research Core Facility, PKD Translational Research Center, Mayo Clinic College of Medicine, Rochester, Minnesota
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James Glockner
4Department of Radiology, Mayo Clinic College of Medicine, Rochester, Minnesota
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Walter K. Kremers
2Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota
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Peter C. Harris
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Nicholas F. LaRusso
5Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota
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Vicente E. Torres
1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota
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Tatyana V. Masyuk
5Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota
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Abstract

Background and objectives We assessed safety and efficacy of another somatostatin receptor analog, pasireotide long-acting release, in severe polycystic liver disease and autosomal dominant polycystic kidney disease. Pasireotide long-acting release, with its broader binding profile and higher affinity to known somatostatin receptors, has potential for greater efficacy.

Design, setting, participants, & measurements 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. Primary outcome was change in total liver volume; secondary outcomes were change in total kidney volume, eGFR, and quality of life.

Results Of 48 subjects randomized, 41 completed total liver volume measurements (n=29 pasireotide long-acting release and n=12 placebo). 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 placebo (P<0.001 for both). 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). Changes in eGFR were similar between groups. 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), 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).

Conclusions Another somatostatin analog, pasireotide long-acting release, slowed progressive increase in both total liver volume/total kidney volume growth rates without affecting GFR decline. Participants experienced higher frequency of adverse events (hyperglycemia and diabetes).

Clinical Trial registry name and registration number Pasireotide LAR in Severe Polycystic Liver Disease, NCT01670110

Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_08_28_CJN13661119.mp3

  • hepatic cyst
  • somatostatin analog
  • polycystic kidney disease
  • liver disease
  • Received November 5, 2019.
  • Accepted June 30, 2020.
  • Copyright © 2020 by the American Society of Nephrology
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Clinical Journal of the American Society of Nephrology: 15 (9)
Clinical Journal of the American Society of Nephrology
Vol. 15, Issue 9
September 07, 2020
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Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement
Marie C. Hogan, Julie A. Chamberlin, Lisa E. Vaughan, Angela L. Waits, Carly Banks, Kathleen Leistikow, Troy Oftsie, Chuck Madsen, Marie Edwards, James Glockner, Walter K. Kremers, Peter C. Harris, Nicholas F. LaRusso, Vicente E. Torres, Tatyana V. Masyuk
CJASN Sep 2020, 15 (9) 1267-1278; DOI: 10.2215/CJN.13661119

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Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement
Marie C. Hogan, Julie A. Chamberlin, Lisa E. Vaughan, Angela L. Waits, Carly Banks, Kathleen Leistikow, Troy Oftsie, Chuck Madsen, Marie Edwards, James Glockner, Walter K. Kremers, Peter C. Harris, Nicholas F. LaRusso, Vicente E. Torres, Tatyana V. Masyuk
CJASN Sep 2020, 15 (9) 1267-1278; DOI: 10.2215/CJN.13661119
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