Effects of Somatostatin on Liver in ADPKD

Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02119052

Enrollment

Registered

2014-04-21

Start date

2009-01-31

Completion date

Unknown

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease

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.

Interventions

DRUGocteotride

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of somatostatin on liver volume	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026