Effects of Somatostatin on Liver in ADPKD
Phase 2
Completed
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Drug: octeotrideDrug: placebo
- Registration Number
- NCT02119052
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCTEOTRIDE octeotride octeotride 20 mg, intramuscular injection monthly for 3 years Placebo placebo Placebo (saline soluction), intramuscular injection monthly for 3 years
- Primary Outcome Measures
Name Time Method Effect of somatostatin on liver volume 3 years
- Secondary Outcome Measures
Name Time Method