Clinical trial NCT02530359: Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury
Official title: Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Sepsis
Keywords: septic acute kidney injury
pirfenidone
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a primary objective.

Detailed description: Septic acute kidney injury (AKI) is the most common cause of AKI in the world, there is no specific treatment for this pathology; the pathophysiology is related to inflammatory pathway and strategies that modulate this are potentially useful. The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment, in animal models has shown a beneficial effect on the recovery of renal function immediately after administrated. The investigators propose a triple blind clinical trial,in which septic AKI patients will be randomized in three arms, all receive conventional treatment KDIGO guides, groupPDF 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days. The Investigators analyze the recovery of renal function as a primary objective, as a secondary objectives clinical variables associated with renal recovery, biochemical variables, inflammatory, molecular variables and measurement of PDF in blood will be analyzed. Patients will be follow-up for 7 days and 28 days after randomization.

Eligibility criteria: Inclusion Criteria:

. sepsis

* AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine \<2 mg / dL)

Exclusion Criteria:

* Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine \> 2mg/dl) known and / or sharpened.

  * chronic dialysis (peritoneal dialysis or hemodialysis)
  * History of AKI and / or RRT in the last three months
  * Pregnancy AKI by other causes other than sepsis

Primary outcomes:
measure: renal function recovery
timeFrame: within the first 7 days
measure: renal function recovery
timeFrame: within the first 28 days
Secondary outcomes:
measure: Urinary Volume
timeFrame: within the first 7 days
measure: need of renal replacement therapy (RRT)
timeFrame: within the first 7 days
measure: mortality
timeFrame: within the first 7 days
measure: serum creatinine levels
timeFrame: within the first 7 days
measure: serum urea levels
timeFrame: within the first 7 days
measure: pirfenidone levels in serum ug/mL
timeFrame: on day 1 and day 7
measure: IL-1
timeFrame: on day 1 and day 7
measure: IL-6
timeFrame: on day 1 and day 7
measure: TNF-α
timeFrame: on day 1 and day 7
measure: Toll-like receptor 4
timeFrame: on day 1 and day 7
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitario Ciencias de la Salud
name: Juan Armenzadriz, Dr
role: STUDY_DIRECTOR
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