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Effects of Somatostatin on Liver in ADPKD

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ClinicalTrials.gov Identifier: NCT02119052
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

Brief Summary:

Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.


Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: octeotride Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease
Study Start Date : January 2009
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: OCTEOTRIDE
octeotride 20 mg, intramuscular injection monthly for 3 years
Drug: octeotride
Placebo Comparator: Placebo
Placebo (saline soluction), intramuscular injection monthly for 3 years
Drug: placebo



Primary Outcome Measures :
  1. Effect of somatostatin on liver volume [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of autosomal dominant polycystic kidney and liver disease
  • glomerular filtration rate greater than 40 ml/min

Exclusion Criteria:

  • diabetes mellitus
  • proteinuria greater than 1 g/24 hours
  • significant glomerular disease
  • urinary tract lithiasis and infections
  • symptomatic gallstones
  • biliary sludge
  • cancer
  • pregnant women
  • lactanting women

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT02119052    
Other Study ID Numbers: ADPKD-liver
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs