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Pirfenidone Effect on the Rec...

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

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

Pirfenidone extended release

Intervention Type DRUG

Pirfenidone extended release 600mg per mouth

Group 2

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

Group Type ACTIVE_COMPARATOR

Pirfenidone extended release

Intervention Type DRUG

Pirfenidone extended release 600mg per mouth

Placebo equivalent

Intervention Type DRUG

Placebo equivalent per mouth

Group 3

Placebo equivalent per mouth every 12 hrs for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo equivalent

Intervention Type DRUG

Placebo equivalent per mouth

Interventions

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Pirfenidone extended release

Pirfenidone extended release 600mg per mouth

Intervention Type DRUG

Placebo equivalent

Placebo equivalent per mouth

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Jonathan Samuel Chavez Iñiguez

Nephrologhist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Armenzadriz, Dr

Role: STUDY_DIRECTOR

Centro Universitario Ciencias de la Salud

Central Contacts

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Jonathan Chavez, Dr

Role: CONTACT

[email protected]

0443313299609

Guillermo Garcia, Dr

Role: CONTACT

[email protected]

0443336622288

References

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Chavez-Iniguez JS, Poo JL, Ibarra-Estrada M, Garcia-Benavides L, Navarro-Blackaller G, Cervantes-Sanchez C, Nungaray-Pacheco E, Medina-Gonzalez R, Armendariz-Borunda J, Garcia-Garcia G. Effect of Prolonged-Release Pirfenidone on Renal Function in Septic Acute Kidney Injury Patients: A Double-Blind Placebo-Controlled Clinical Trial. Int J Nephrol. 2021 Jan 13;2021:8833278. doi: 10.1155/2021/8833278. eCollection 2021.

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Other Identifiers

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HCGFAA-DRA-PFD

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

STarting incrEmental Prescription of Peritoneal Dialysis

The Effect of Home Based Tele-Exercise on Peritoneal Dialysis Patients

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

Detailed Description

Conditions

Study Design

Study Groups

Group 1

Pirfenidone extended release

Group 2

Pirfenidone extended release

Placebo equivalent

Group 3

Placebo equivalent

Interventions

Pirfenidone extended release

Placebo equivalent

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hospital Civil de Guadalajara

Responsible Party

Jonathan Samuel Chavez Iñiguez

Principal Investigators

Juan Armenzadriz, Dr

Central Contacts

Jonathan Chavez, Dr

Guillermo Garcia, Dr

References

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