Acute Kidney InjuryPhase 4AKINCT02530359
Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury
A Phase 4 study testing Pirfenidone extended release in people with Acute Kidney Injury and Sepsis, run by Hospital Civil de Guadalajara.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Sepsis
- What is being tested?
- Pirfenidone extended release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . sepsis
- AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine <2 mg / dL)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Sepsis
- Being tested
- Pirfenidone extended release, Placebo equivalent
- Keywords
- septic acute kidney injury, pirfenidone
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone extended releaseDrug
Pirfenidone extended release 600mg per mouth
Placebo equivalentDrug
Also called Placebo
Placebo equivalent per mouth
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Pirfenidone extended release 600mg per mouth every 12 hours for 7 days. Receives: 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. Receives: Drug: Pirfenidone extended release; Drug: Placebo equivalent |
| Group 3 | Placebo comparator | Placebo equivalent per mouth every 12 hrs for 7 days. Receives: Drug: Placebo equivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function recovery
serum creatinine in serum <2mg/dl and urinary output >1,200 ml/day
Measured: within the first 7 days
renal function recovery
serum creatinine in serum <2mg/dl and urinary output >1,200ml/day
Measured: within the first 28 days
Secondary outcomes (10)
Urinary Volume
Urinary Volume in milliliters in 24 hours
Measured: within the first 7 days
need of renal replacement therapy (RRT)
the patient still need renal replacement (RRT) by the judgment of the nephrologist.
Measured: within the first 7 days
mortality
the patient dead
Measured: within the first 7 days
serum creatinine levels
serum creatinine levels in mg/dL
Measured: within the first 7 days
serum urea levels
serum urea levels in mg/dL
Measured: within the first 7 days
pirfenidone levels in serum ug/mL
pirfenidone levels in serum ug/mL
Measured: on day 1 and day 7
IL-1
Interleucin 1 in serum pg/mL
Measured: on day 1 and day 7
IL-6
Interleucin 6 in serum pg/mL
Measured: on day 1 and day 7
TNF-α
tumor necrosis factor in serum pg/dL
Measured: on day 1 and day 7
Toll-like receptor 4
Toll-like receptor 4 in serum pg/dL
Measured: on day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara
- Investigators
- Juan Armenzadriz, Dr, Study director, Centro Universitario Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530359
- Sponsor's protocol ID
- HCGFAA-DRA-PFD
- Acronym
- AKI
- Status last verified
- Aug 2015
- First submitted
- 17 Jun 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu CY. Where is the epidemic in kidney disease? J Am Soc Nephrol. 2010 Oct;21(10):1607-11. doi: 10.1681/ASN.2010050546. Epub 2010 Sep 2. No abstract available.
PubMed 20813868Hsu RK, McCulloch CE, Dudley RA, Lo LJ, Hsu CY. Temporal changes in incidence of dialysis-requiring AKI. J Am Soc Nephrol. 2013 Jan;24(1):37-42. doi: 10.1681/ASN.2012080800. Epub 2012 Dec 6.
PubMed 23222124James M, Pannu N. Methodological considerations for observational studies of acute kidney injury using existing data sources. J Nephrol. 2009 May-Jun;22(3):295-305.
PubMed 19557705Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
PubMed 16106006Brivet FG, Kleinknecht DJ, Loirat P, Landais PJ. Acute renal failure in intensive care units--causes, outcome, and prognostic factors of hospital mortality; a prospective, multicenter study. French Study Group on Acute Renal Failure. Crit Care Med. 1996 Feb;24(2):192-8. doi: 10.1097/00003246-199602000-00003.
PubMed 8605788Mehta RL, Pascual MT, Soroko S, Savage BR, Himmelfarb J, Ikizler TA, Paganini EP, Chertow GM; Program to Improve Care in Acute Renal Disease. Spectrum of acute renal failure in the intensive care unit: the PICARD experience. Kidney Int. 2004 Oct;66(4):1613-21. doi: 10.1111/j.1523-1755.2004.00927.x.
PubMed 15458458Metcalfe W, Simpson M, Khan IH, Prescott GJ, Simpson K, Smith WC, MacLeod AM; Scottish Renal Registry. Acute renal failure requiring renal replacement therapy: incidence and outcome. QJM. 2002 Sep;95(9):579-83. doi: 10.1093/qjmed/95.9.579.
PubMed 12205335Grams ME, Rabb H. The distant organ effects of acute kidney injury. Kidney Int. 2012 May;81(10):942-948. doi: 10.1038/ki.2011.241. Epub 2011 Aug 3.
PubMed 21814177Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
PubMed 21975865Heyman SN, Evans RG, Rosen S, Rosenberger C. Cellular adaptive changes in AKI: mitigating renal hypoxic injury. Nephrol Dial Transplant. 2012 May;27(5):1721-8. doi: 10.1093/ndt/gfs100.
PubMed 22547749Heyman SN, Rosenberger C, Rosen S. Experimental ischemia-reperfusion: biases and myths-the proximal vs. distal hypoxic tubular injury debate revisited. Kidney Int. 2010 Jan;77(1):9-16. doi: 10.1038/ki.2009.347.
PubMed 19759527Kinsey GR, Sharma R, Okusa MD. Regulatory T cells in AKI. J Am Soc Nephrol. 2013 Nov;24(11):1720-6. doi: 10.1681/ASN.2013050502. Epub 2013 Oct 17.
PubMed 24136922Kaushal GP, Shah SV. Challenges and advances in the treatment of AKI. J Am Soc Nephrol. 2014 May;25(5):877-83. doi: 10.1681/ASN.2013070780. Epub 2014 Jan 30.
PubMed 24480828Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.
PubMed 11979336Mehta RL. Management of acute kidney injury: it's the squeaky wheel that gets the oil! Clin J Am Soc Nephrol. 2011 Sep;6(9):2102-4. doi: 10.2215/CJN.07720811. Epub 2011 Aug 18. No abstract available.
PubMed 21852670
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02530359
- Acronym / sponsor ID
- AKI / HCGFAA-DRA-PFD
- Conditions
- Acute Kidney Injury, Sepsis
- Keywords
- septic acute kidney injury, pirfenidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Pirfenidone extended releasePirfenidone extended release 600mg per mouth every 12 hours for 7 days. |
| Group 2 | Active comparator | Drug: Pirfenidone extended release, Drug: Placebo equivalentPirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days. |
| Group 3 | Placebo comparator | Drug: Placebo equivalentPlacebo equivalent per mouth every 12 hrs for 7 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- . sepsis
- AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine <2 mg / dL)
Key exclusion criteria (4 listed)
- Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine > 2mg/dl) known and / or sharpened.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone extended releasePirfenidone extended release 600mg per mouth | Drug | Group 1, Group 2 |
| Placebo equivalentAlso: PlaceboPlacebo equivalent per mouth | Drug | Group 2, Group 3 |
Primary outcome
renal function recovery
Time frame: within the first 7 days
serum creatinine in serum <2mg/dl and urinary output >1,200 ml/day
renal function recovery
Time frame: within the first 28 days
serum creatinine in serum <2mg/dl and urinary output >1,200ml/day
10 secondary outcomes
Urinary Volume
Time frame: within the first 7 days
need of renal replacement therapy (RRT)
Time frame: within the first 7 days
mortality
Time frame: within the first 7 days
serum creatinine levels
Time frame: within the first 7 days
serum urea levels
Time frame: within the first 7 days
pirfenidone levels in serum ug/mL
Time frame: on day 1 and day 7
IL-1
Time frame: on day 1 and day 7
IL-6
Time frame: on day 1 and day 7
TNF-α
Time frame: on day 1 and day 7
Toll-like receptor 4
Time frame: on day 1 and day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Background: PubMed 20813868Hsu CY. Where is the epidemic in kidney disease? J Am Soc Nephrol. 2010 Oct;21(10):1607-11. doi: 10.1681/ASN.2010050546. Epub 2010 Sep 2. No abstract available.
- Background: PubMed 23222124Hsu RK, McCulloch CE, Dudley RA, Lo LJ, Hsu CY. Temporal changes in incidence of dialysis-requiring AKI. J Am Soc Nephrol. 2013 Jan;24(1):37-42. doi: 10.1681/ASN.2012080800. Epub 2012 Dec 6.
- Background: PubMed 19557705James M, Pannu N. Methodological considerations for observational studies of acute kidney injury using existing data sources. J Nephrol. 2009 May-Jun;22(3):295-305.
- Background: PubMed 16106006Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
- Background: PubMed 8605788Brivet FG, Kleinknecht DJ, Loirat P, Landais PJ. Acute renal failure in intensive care units--causes, outcome, and prognostic factors of hospital mortality; a prospective, multicenter study. French Study Group on Acute Renal Failure. Crit Care Med. 1996 Feb;24(2):192-8. doi: 10.1097/00003246-199602000-00003.
- Background: PubMed 15458458Mehta RL, Pascual MT, Soroko S, Savage BR, Himmelfarb J, Ikizler TA, Paganini EP, Chertow GM; Program to Improve Care in Acute Renal Disease. Spectrum of acute renal failure in the intensive care unit: the PICARD experience. Kidney Int. 2004 Oct;66(4):1613-21. doi: 10.1111/j.1523-1755.2004.00927.x.
- Background: PubMed 12205335Metcalfe W, Simpson M, Khan IH, Prescott GJ, Simpson K, Smith WC, MacLeod AM; Scottish Renal Registry. Acute renal failure requiring renal replacement therapy: incidence and outcome. QJM. 2002 Sep;95(9):579-83. doi: 10.1093/qjmed/95.9.579.
- Background: PubMed 21814177Grams ME, Rabb H. The distant organ effects of acute kidney injury. Kidney Int. 2012 May;81(10):942-948. doi: 10.1038/ki.2011.241. Epub 2011 Aug 3.
- Background: PubMed 21975865Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
- Background: PubMed 22547749Heyman SN, Evans RG, Rosen S, Rosenberger C. Cellular adaptive changes in AKI: mitigating renal hypoxic injury. Nephrol Dial Transplant. 2012 May;27(5):1721-8. doi: 10.1093/ndt/gfs100.
- Background: PubMed 19759527Heyman SN, Rosenberger C, Rosen S. Experimental ischemia-reperfusion: biases and myths-the proximal vs. distal hypoxic tubular injury debate revisited. Kidney Int. 2010 Jan;77(1):9-16. doi: 10.1038/ki.2009.347.
- Background: PubMed 24136922Kinsey GR, Sharma R, Okusa MD. Regulatory T cells in AKI. J Am Soc Nephrol. 2013 Nov;24(11):1720-6. doi: 10.1681/ASN.2013050502. Epub 2013 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Armenzadriz, Dr study director
Centro Universitario Ciencias de la Salud
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pirfenidone extended release in people with Acute Kidney Injury and Sepsis, run by Hospital Civil de Guadalajara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Chavez, Dr (0443313299609, jonarchi_10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function recovery (time frame: within the first 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530359, which also lists 66 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.