Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury
- Conditions
- Acute Kidney InjurySepsis
- Interventions
- Drug: Placebo equivalent
- Registration Number
- NCT02530359
- Lead Sponsor
- Hospital Civil de Guadalajara
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
. sepsis
- AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine <2 mg / dL)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Pirfenidone extended release Pirfenidone extended release 600mg per mouth every 12 hours for 7 days. Group 2 Placebo equivalent Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days. Group 3 Placebo equivalent Placebo equivalent per mouth every 12 hrs for 7 days. Group 2 Pirfenidone extended release Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.
- Primary Outcome Measures
Name Time Method renal function recovery within the first 28 days serum creatinine in serum \<2mg/dl and urinary output \>1,200ml/day
- Secondary Outcome Measures
Name Time Method Urinary Volume within the first 7 days Urinary Volume in milliliters in 24 hours
serum urea levels within the first 7 days serum urea levels in mg/dL
pirfenidone levels in serum ug/mL on day 1 and day 7 pirfenidone levels in serum ug/mL
need of renal replacement therapy (RRT) within the first 7 days the patient still need renal replacement (RRT) by the judgment of the nephrologist.
mortality within the first 7 days the patient dead
serum creatinine levels within the first 7 days serum creatinine levels in mg/dL
IL-1 on day 1 and day 7 Interleucin 1 in serum pg/mL
IL-6 on day 1 and day 7 Interleucin 6 in serum pg/mL
TNF-α on day 1 and day 7 tumor necrosis factor in serum pg/dL
Toll-like receptor 4 on day 1 and day 7 Toll-like receptor 4 in serum pg/dL