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

August 19, 2015 updated by: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Pirfenidone extended release 600mg per mouth every 12 hours for 7 days.
Drug: Pirfenidone extended release
Pirfenidone extended release 600mg per mouth
Active Comparator: Group 2
Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.
Drug: Pirfenidone extended release
Pirfenidone extended release 600mg per mouth
Drug: Placebo equivalent
Placebo equivalent per mouth
Other Names:
  • Placebo
Placebo Comparator: Group 3
Placebo equivalent per mouth every 12 hrs for 7 days.
Drug: Placebo equivalent
Placebo equivalent per mouth
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal function recovery
Time Frame: within the first 7 days
serum creatinine in serum <2mg/dl and urinary output >1,200 ml/day
within the first 7 days
renal function recovery
Time Frame: within the first 28 days
serum creatinine in serum <2mg/dl and urinary output >1,200ml/day
within the first 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Volume
Time Frame: within the first 7 days
Urinary Volume in milliliters in 24 hours
within the first 7 days
need of renal replacement therapy (RRT)
Time Frame: within the first 7 days
the patient still need renal replacement (RRT) by the judgment of the nephrologist.
within the first 7 days
mortality
Time Frame: within the first 7 days
the patient dead
within the first 7 days
serum creatinine levels
Time Frame: within the first 7 days
serum creatinine levels in mg/dL
within the first 7 days
serum urea levels
Time Frame: within the first 7 days
serum urea levels in mg/dL
within the first 7 days
pirfenidone levels in serum ug/mL
Time Frame: on day 1 and day 7
pirfenidone levels in serum ug/mL
on day 1 and day 7
IL-1
Time Frame: on day 1 and day 7
Interleucin 1 in serum pg/mL
on day 1 and day 7
IL-6
Time Frame: on day 1 and day 7
Interleucin 6 in serum pg/mL
on day 1 and day 7
TNF-α
Time Frame: on day 1 and day 7
tumor necrosis factor in serum pg/dL
on day 1 and day 7
Toll-like receptor 4
Time Frame: on day 1 and day 7
Toll-like receptor 4 in serum pg/dL
on day 1 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Study Director: Juan Armenzadriz, Dr, Centro Universitario Ciencias de la Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCGFAA-DRA-PFD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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