Effects of Somatostatin on Liver in ADPKD

Phase 3CompletedNCT02119052

Federico II University35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

octeotrideDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Effect of somatostatin on liver volume

Time frame: 3 years

Data from ClinicalTrials.gov

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