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

Sepsis Clinical Trial

— AKI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02530359
• Other study ID #: HCGFAA-DRA-PFD
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 17, 2015
• Last updated: August 19, 2015
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: Hospital Civil de Guadalajara
• Contact: Jonathan Chavez, Dr
• Phone: 0443313299609
• Email: jonarchi_10[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis

Intervention

Drug:
• Pirfenidone extended release
Pirfenidone extended release 600mg per mouth
• Placebo equivalent
Placebo equivalent per mouth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

References & Publications (65)

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* Note: There are 65 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function recovery	serum creatinine in serum <2mg/dl and urinary output >1,200 ml/day	within the first 7 days	No
Primary	renal function recovery	serum creatinine in serum <2mg/dl and urinary output >1,200ml/day	within the first 28 days	No
Secondary	Urinary Volume	Urinary Volume in milliliters in 24 hours	within the first 7 days	No
Secondary	need of renal replacement therapy (RRT)	the patient still need renal replacement (RRT) by the judgment of the nephrologist.	within the first 7 days	No
Secondary	mortality	the patient dead	within the first 7 days	No
Secondary	serum creatinine levels	serum creatinine levels in mg/dL	within the first 7 days	No
Secondary	serum urea levels	serum urea levels in mg/dL	within the first 7 days	No
Secondary	pirfenidone levels in serum ug/mL	pirfenidone levels in serum ug/mL	on day 1 and day 7	No
Secondary	IL-1	Interleucin 1 in serum pg/mL	on day 1 and day 7	No
Secondary	IL-6	Interleucin 6 in serum pg/mL	on day 1 and day 7	No
Secondary	TNF-a	tumor necrosis factor in serum pg/dL	on day 1 and day 7	No
Secondary	Toll-like receptor 4	Toll-like receptor 4 in serum pg/dL	on day 1 and day 7	No