Effects of Somatostatin on Liver in ADPKD

April 18, 2014 updated by: Eleonora Riccio, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCTEOTRIDE
octeotride 20 mg, intramuscular injection monthly for 3 years
Drug: octeotride
Placebo Comparator: Placebo
Placebo (saline soluction), intramuscular injection monthly for 3 years
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of somatostatin on liver volume
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADPKD-liver

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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