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NCT02119052 Clinical Trial

Effects of Somatostatin on Liver in ADPKD

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02119052
Other study ID # ADPKD-liver
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received April 17, 2014
Last updated April 18, 2014
Start date January 2009

Study information
Verified date January 2014
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Commettee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• octeotride

• placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of somatostatin on liver volume 3 years No
See also
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