Trial intelligence / Profile preview

Pasireotide LAR in Severe Polycystic Liver Disease

NCT01670110Phase 2

Key facts

Status: Completed
Start: Aug 2012
Primary completion: Sep 2018
Countries: 1
Sponsor: Mayo Clinic
Modality: Peptides, Small Molecules

Drugs: pasireotide LAR
Conditions: Polycystic liver disease (PLD)autosomal dominant polycystic kidney disease (ADPKD)

Overview

Phase 2, randomised, double-blind trial in Polycystic liver disease (PLD) and autosomal dominant polycystic kidney disease (ADPKD) comparing Pasireotide LAR with Placebo (2 arms). Primary endpoints: Change in Liver Volume at 12 months and Change in Kidney Volume at 12 months. Started Aug 2012; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Pasireotide LAR
Active treatment arm
Placebo
Placebo control arm

Who it enrols

Adults with severe polycystic liver disease (liver volume > 4000mL or symptomatic) associated with ADPKD or ADPLD, with adequate organ function and no history of significant liver disease or uncontrolled diabetes.

Endpoints

Primary

Change in Liver Volume12 months
Change in Kidney Volume12 months

Secondary

Percentage Change in Estimated Glomerular Filtration Rate12 months
Percentage Change in Serum Creatinine12 months
Percent Change in Blood Glucose12 months
Percentage Change in Hemoglobin A1C12 months
Percentage Change in Heart Rate12 months
Change in Quality of Life12 months

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