Phenylbutyrate in Proteinuric Nephropathies
PIRATE
Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2015
Shorter than P25 for phase_2
1 active site
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
First Submitted
Initial submission to the registry
January 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 21, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedNovember 20, 2025
October 1, 2025
10 months
January 15, 2015
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Lcn2/creatinine ratio
Reduction of 50 % of Lcn2 concentration, measured with ELISA
Day 7, Day 15, Day 21, Day 28
Secondary Outcomes (4)
Urinary protein/creatinine ratio
Day 7
Urinary protein/creatinine ratio
Day 15
Urinary protein/creatinine ratio
Day 21
Urinary protein/creatinine ratio
Day 28
Study Arms (2)
PBA 7,5g/d
EXPERIMENTALTreatment for 14 days
PBA 15g/d
EXPERIMENTALTreatment for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Chronic Kidney disease for ore than 3 months
- Proteinuria \> 1g/d or 0,1g/mmmol creatinine
- eGFR \>30ml/mn/1,73m2
- written informed consent
- affiliated with social security health insurance
You may not qualify if:
- Women with childbearing potential
- Recent (\<3 months) modification of ACE inhibitors or ARB
- Acute renal failure
- eGFR \<30ml/mn/1,73m2
- Nephrotic syndrome (albuminélia \<30g/l)
- Infection with HIV, HCV, HBV
- Liver insufficiency
- No affiliated with social security health insurance
- risk of non-adherence to protocol and visits
- patients having a cardiac insufficiency of grade 3 or 4
- patient requiring of a strict salt-free diet
- patients under corticoids or immunosuppresseurs
- clinical intolerance in the treatment
- intolerance in the fructose, the syndrome of malabsorption glucose and galactose or a deficit in sucrase / isomaltase
- patients treated by Probenecide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Necker Enfants Malades
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertrand KNEBELMANN
Service de Néphrologie Adulte, Hôpital Necker
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2015
First Posted
January 21, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
November 20, 2025
Record last verified: 2025-10