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

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ClinicalTrials.gov Identifier: NCT02530359
Recruitment Status : Unknown
Verified August 2015 by Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Sepsis Drug: Pirfenidone extended release Drug: Placebo equivalent Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury
Study Start Date : October 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
Drug Information available for: Pirfenidone
U.S. FDA Resources

Arms and Interventions

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 Name: Placebo
Placebo Comparator: Group 3
Placebo equivalent per mouth every 12 hrs for 7 days.
Drug: Placebo equivalent
Placebo equivalent per mouth
Other Name: Placebo


Outcome Measures

Primary Outcome Measures :
  1. renal function recovery [ Time Frame: within the first 7 days ]
    serum creatinine in serum <2mg/dl and urinary output >1,200 ml/day

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


Secondary Outcome Measures :
  1. Urinary Volume [ Time Frame: within the first 7 days ]
    Urinary Volume in milliliters in 24 hours

  2. 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.

  3. mortality [ Time Frame: within the first 7 days ]
    the patient dead

  4. serum creatinine levels [ Time Frame: within the first 7 days ]
    serum creatinine levels in mg/dL

  5. serum urea levels [ Time Frame: within the first 7 days ]
    serum urea levels in mg/dL

  6. pirfenidone levels in serum ug/mL [ Time Frame: on day 1 and day 7 ]
    pirfenidone levels in serum ug/mL

  7. IL-1 [ Time Frame: on day 1 and day 7 ]
    Interleucin 1 in serum pg/mL

  8. IL-6 [ Time Frame: on day 1 and day 7 ]
    Interleucin 6 in serum pg/mL

  9. TNF-α [ Time Frame: on day 1 and day 7 ]
    tumor necrosis factor in serum pg/dL

  10. Toll-like receptor 4 [ Time Frame: on day 1 and day 7 ]
    Toll-like receptor 4 in serum pg/dL


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530359


Contacts
Contact: Jonathan Chavez, Dr 0443313299609 jonarchi_10@hotmail.com
Contact: Guillermo Garcia, Dr 0443336622288 ggarcia1952@gmail.com

Sponsors and Collaborators
Hospital Civil de Guadalajara
Investigators
Study Director: Juan Armenzadriz, Dr Centro Universitario Ciencias de la Salud
More Information

Publications:
24. A study to evaluate the safety and efficacy of AC607 for the treatment of kidney injury in cardiac surgery subjects (ACT-AKI).
46. Hartung J: A note on combining dependent tests of significance. Biometrical J 1999, 41:849-855.

Responsible Party: Jonathan Samuel Chavez Iñiguez, Nephrologhist, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT02530359     History of Changes
Other Study ID Numbers: HCGFAA-DRA-PFD
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara:
septic acute kidney injury
pirfenidone

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents