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Phenylbutyrate in Proteinuric Nephropathies (PIRATE)

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ClinicalTrials.gov Identifier: NCT02343094
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.

Condition or disease Intervention/treatment Phase
Proteinuric Diseases Drug: PBA 7,5g/d Drug: PBA 15g/d Phase 2 Phase 3

Detailed Description:

Proteinuria is a major prognosis factor of chronic kidney disease (CKD) progression. Convergent evidences from clinical and experimental studies indicate that albuminuria and proteinuria are not simply a marker of CKD progression, but an active player in the evolution of the disease. Mechanistically, it has been shown that proteinuria induces endoplasmic reticulum stress in tubular cells, leading to induction of lipocalin 2/NGAL, a critical element of CKD progression. Moreover, proteinuric mice treated with phenylbutyrate are protected from CKD progression.

The aim of this study is to evaluate the efficacy of phenybutyrate, a molecular chaperone which inhibits ER stress, on the proteinuria-induced NGAL expression. Urinary NGAL/creatinine ratio will be evaluated in proteinuric patients before and under treatment with phenylbutyrate.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PBA 7,5g/d
Treatment for 14 days
Drug: PBA 7,5g/d
Treatment for 14 days with PBA

Experimental: PBA 15g/d
Treatment for 14 days
Drug: PBA 15g/d
Treatment for 14 days with PBA




Primary Outcome Measures :
  1. Urinary Lcn2/creatinine ratio [ Time Frame: Day 7, Day 15, Day 21, Day 28 ]
    Reduction of 50 % of Lcn2 concentration, measured with ELISA


Secondary Outcome Measures :
  1. Urinary protein/creatinine ratio [ Time Frame: Day 7 ]
    Reduction of 30% of the proteinurie and the albuminuria

  2. Urinary protein/creatinine ratio [ Time Frame: Day 15 ]
    Reduction of 30% of the proteinurie and the albuminuria

  3. Urinary protein/creatinine ratio [ Time Frame: Day 21 ]
    Reduction of 30% of the proteinurie and the albuminuria

  4. Urinary protein/creatinine ratio [ Time Frame: Day 28 ]
    Reduction of 30% of the proteinurie and the albuminuria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • inclusion in another protocol of biomedical research
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343094


Locations
France
Hôpital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bertrand KNEBELMANN Service de Néphrologie Adulte, Hôpital Necker

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02343094     History of Changes
Other Study ID Numbers: 2013-003924-35
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Proteinuria
Lipocalin 2
Neutrophil gelatinase associated lipocalin
ELISA

Additional relevant MeSH terms:
4-phenylbutyric acid
Antineoplastic Agents