Effects of Somatostatin on Liver in ADPKD

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Somatostatin

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