Effects of Somatostatin on Liver in ADPKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OCTEOTRIDE

octeotride 20 mg, intramuscular injection monthly for 3 years

Group Type EXPERIMENTAL

octeotride

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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octeotride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No