Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury (AKI)

Hospital Civil de Guadalajara

Status and phase: Unknown; Phase 4

Conditions: Acute Kidney Injury; Sepsis

Treatments: Drug: Placebo equivalent; Drug: Pirfenidone extended release

Study type: Interventional

Funder types: Other

Identifiers

NCT02530359

HCGFAA-DRA-PFD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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

Treatment:

Drug: Pirfenidone extended release

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Placebo equivalent

Drug: Pirfenidone extended release

Group 3

Placebo Comparator group

Description:

Placebo equivalent per mouth every 12 hrs for 7 days.

Treatment:

Drug: Placebo equivalent