Effects of Somatostatin on Liver in ADPKD

Federico II University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Autosomal Dominant Polycystic Kidney Disease

Treatments: Drug: octeotride; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02119052

ADPKD-liver

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

OCTEOTRIDE

Experimental group

Description:

octeotride 20 mg, intramuscular injection monthly for 3 years

Treatment:

Drug: octeotride

Placebo

Placebo Comparator group

Description:

Placebo (saline soluction), intramuscular injection monthly for 3 years

Treatment:

Drug: placebo