Effects of Somatostatin on Liver in ADPKD
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
octeotride
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OCTEOTRIDE
Placebo
Arm Description
octeotride 20 mg, intramuscular injection monthly for 3 years
Placebo (saline soluction), intramuscular injection monthly for 3 years
Outcomes
Primary Outcome Measures
Effect of somatostatin on liver volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02119052
Brief Title
Effects of Somatostatin on Liver in ADPKD
Official Title
Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCTEOTRIDE
Arm Type
Experimental
Arm Description
octeotride 20 mg, intramuscular injection monthly for 3 years
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (saline soluction), intramuscular injection monthly for 3 years
Intervention Type
Drug
Intervention Name(s)
octeotride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Effect of somatostatin on liver volume
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26844873
Citation
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.
Results Reference
derived
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Effects of Somatostatin on Liver in ADPKD
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