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

NCT02530359 | Unknown Phase 4 DMC

• 1 other identifier: HCGFAA-DRA-PFD
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury; Sepsis

Keywords

septic acute kidney injury; pirfenidone

Outcome Measures

Primary Outcomes (2)

• renal function recovery

  serum creatinine in serum \<2mg/dl and urinary output \>1,200 ml/day

  within the first 7 days

• renal function recovery

  serum creatinine in serum \<2mg/dl and urinary output \>1,200ml/day

  within the first 28 days

Secondary Outcomes (10)

• Urinary Volume

  within the first 7 days

• need of renal replacement therapy (RRT)

  within the first 7 days

• mortality

  within the first 7 days

• serum creatinine levels

  within the first 7 days

• serum urea levels

  within the first 7 days

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Drug: Pirfenidone extended release

Group 2

ACTIVE COMPARATOR

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; Drug: Placebo equivalent

Group 3

PLACEBO COMPARATOR

Placebo equivalent per mouth every 12 hrs for 7 days.

Drug: Placebo equivalent

Interventions

Pirfenidone extended release DRUG

Pirfenidone extended release 600mg per mouth

Group 1; Group 2

Placebo equivalent DRUG

Placebo equivalent per mouth

Also known as: Placebo

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sepsis
• AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine \<2 mg / dL)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

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MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Armenzadriz, Dr

  Centro Universitario Ciencias de la Salud

  STUDY DIRECTOR

Central Study Contacts

Jonathan Chavez, Dr

CONTACT

0443313299609; jonarchi_10@hotmail.com

Guillermo Garcia, Dr

CONTACT

0443336622288; ggarcia1952@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologhist

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: August 21, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 21, 2015

Record last verified: 2015-08