Trial | NCT02530359  Report issue

Title

Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury
Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    pirfenidone ...

  • Study Participants

    90
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.
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.
Study Started
Oct 31
2015
Primary Completion
Mar 31
2016
Anticipated
Study Completion
Jul 31
2016
Anticipated
Last Update
Aug 21
2015
Estimate

Drug Pirfenidone extended release

Pirfenidone extended release 600mg per mouth

Drug Placebo equivalent

Placebo equivalent per mouth

  • Other names: Placebo

Group 1 Active Comparator

Pirfenidone extended release 600mg per mouth every 12 hours for 7 days.

Group 2 Active Comparator

Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.

Group 3 Placebo Comparator

Placebo equivalent per mouth every 12 hrs for 7 days.

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
No Results Posted