NCT02119052

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

January 1, 2014

Enrollment Period

4.7 years

First QC Date

April 17, 2014

Last Update Submit

April 18, 2014

Conditions

Autosomal Dominant Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Effect of somatostatin on liver volume

    3 years

Study Arms (2)

OCTEOTRIDE

EXPERIMENTAL

octeotride 20 mg, intramuscular injection monthly for 3 years

Drug: octeotride

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

octeotrideDRUG
OCTEOTRIDE
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of autosomal dominant polycystic kidney and liver disease
  • glomerular filtration rate greater than 40 ml/min

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pisani A, Sabbatini M, Imbriaco M, Riccio E, Rubis N, Prinster A, Perna A, Liuzzi R, Spinelli L, Santangelo M, Remuzzi G, Ruggenenti P; ALADIN Study Group. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030.e4. doi: 10.1016/j.cgh.2015.12.049. Epub 2016 Feb 1.

    PMID: 26844873DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 21, 2014

Study Start

January 1, 2009

Primary Completion

September 1, 2013

Last Updated

April 21, 2014

Record last verified: 2014-01