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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02530359
Acronym
AKI
Enrollment
90
Registered
2015-08-21
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis

Keywords

septic acute kidney injury, pirfenidone

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.

Interventions

Placebo equivalent per mouth

DRUGPirfenidone extended release

Pirfenidone extended release 600mg per mouth

Sponsors

Hospital Civil de Guadalajara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
renal function recoverywithin the first 7 daysserum creatinine in serum \<2mg/dl and urinary output \>1,200 ml/day

Secondary

MeasureTime frameDescription
IL-1on day 1 and day 7Interleucin 1 in serum pg/mL
IL-6on day 1 and day 7Interleucin 6 in serum pg/mL
TNF-αon day 1 and day 7tumor necrosis factor in serum pg/dL
Toll-like receptor 4on day 1 and day 7Toll-like receptor 4 in serum pg/dL
pirfenidone levels in serum ug/mLon day 1 and day 7pirfenidone levels in serum ug/mL
need of renal replacement therapy (RRT)within the first 7 daysthe patient still need renal replacement (RRT) by the judgment of the nephrologist.
mortalitywithin the first 7 daysthe patient dead
serum creatinine levelswithin the first 7 daysserum creatinine levels in mg/dL
serum urea levelswithin the first 7 daysserum urea levels in mg/dL
Urinary Volumewithin the first 7 daysUrinary Volume in milliliters in 24 hours

Contacts

Primary ContactJonathan Chavez, Dr
jonarchi_10@hotmail.com0443313299609
Backup ContactGuillermo Garcia, Dr
ggarcia1952@gmail.com0443336622288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026