Acute Renal FailurePhase 3FENO HSRNCT00621790
Fenoldopam and Acute Renal Failure
A Phase 3 study testing fenoldopam in people with Acute Renal Failure, run by Università Vita-Salute San Raffaele at 19 sites in Italy.
Trial summary
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy. Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- fenoldopam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 667 participants
- Where
- 19 sitesItaly
- Study dates
- Feb 2008to Jun 2013
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- who underwent cardiac surgery
- have Risk of Acute Renal Failure (R of RIFLE score)
Who cannot join
- glaucoma
- already on renal replacement therapy
- study drug in the past 30 days
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
A.O. Universitario Policlinico S.Orsola Malpighi
Bologna
Pres.Ospedal. Spedali Civili Brescia - Brescia
Brescia
Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
Catanzaro
Azienda Ospedaliero Universitaria Careggi - Firenze
Florence
Città di Lecce Hospital GVM Care and Research Lecce
Lecce
Villa Maria Cecilia di Cotignola
Lugo Di Ravenna
Azienda Ospedaliera Papardo - Messina
Messina
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, 20132
Azienda Ospedaliera Vincenzo Monaldi - Napoli
Naples
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
Perugia
Azienda Ospedaliero Universitaria Pisana - Pisa
Pisa
A.O.Universitario Policlinico Tor Vergata - Roma
Roma
Ospedale Civile SS Annunziata di Sassari
Sassari
Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
Siena
Azienda Ospedaliera San Giovanni Battista Molinette di Torino
Torino
Ospedale Mauriziano Umberto I di Torino
Torino
Ospedale S.Maria di Ca' Foncello
Treviso
Azienda Ospedaliera Universitaria Santa Maria della Misericordia
Udine
About this study
Official title: Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.
Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
- Conditions
- Acute Renal Failure
- Being tested
- fenoldopam, placebo
- Keywords
- fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenoldopamDrug
Also called corlopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Fenoldopam | Experimental | Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days Receives: Drug: fenoldopam |
| Placebo | Placebo comparator | Placebo (normosaline), continuous perfusion Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring Renal Replacement Therapy
Measured: participants will be followed for the duration of intensive care unit stay, an expected average of one week
Secondary outcomes (1)
Number of dead patients.
Measured: Participants will be followed for 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621790
- Sponsor's protocol ID
- GO/URC/ER/mm 64/DG
- Acronym
- FENO HSR
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
Publications
Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
PubMed 39607014Bove T, Zangrillo A, Guarracino F, Alvaro G, Persi B, Maglioni E, Galdieri N, Comis M, Caramelli F, Pasero DC, Pala G, Renzini M, Conte M, Paternoster G, Martinez B, Pinelli F, Frontini M, Zucchetti MC, Pappalardo F, Amantea B, Camata A, Pisano A, Verdecchia C, Dal Checco E, Cariello C, Faita L, Baldassarri R, Scandroglio AM, Saleh O, Lembo R, Calabro MG, Bellomo R, Landoni G. Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2244-53. doi: 10.1001/jama.2014.13573.
PubMed 25265449
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00621790
- Acronym / sponsor ID
- FENO HSR / GO/URC/ER/mm 64/DG
- Conditions
- Acute Renal Failure
- Keywords
- fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Feb 2008 (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 undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.
Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenoldopam | Experimental | Drug: fenoldopamFenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days |
| Placebo | Placebo comparator | Drug: placeboPlacebo (normosaline), continuous perfusion |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- who underwent cardiac surgery
- have Risk of Acute Renal Failure (R of RIFLE score)
Key exclusion criteria (3 listed)
- glaucoma
- already on renal replacement therapy
- study drug in the past 30 days
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 |
|---|---|---|
| fenoldopamAlso: corlopamfenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days | Drug | Fenoldopam |
| placeboplacebo | Drug | Placebo |
Primary outcome
Number of patients requiring Renal Replacement Therapy
Time frame: participants will be followed for the duration of intensive care unit stay, an expected average of one week
1 secondary outcome
Number of dead patients.
Time frame: Participants will be followed for 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 39607014Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
- Derived from this study: PubMed 25265449Bove T, Zangrillo A, Guarracino F, Alvaro G, Persi B, Maglioni E, Galdieri N, Comis M, Caramelli F, Pasero DC, Pala G, Renzini M, Conte M, Paternoster G, Martinez B, Pinelli F, Frontini M, Zucchetti MC, Pappalardo F, Amantea B, Camata A, Pisano A, Verdecchia C, Dal Checco E, Cariello C, Faita L, Baldassarri R, Scandroglio AM, Saleh O, Lembo R, Calabro MG, Bellomo R, Landoni G. Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2244-53. doi: 10.1001/jama.2014.13573.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fenoldopam in people with Acute Renal Failure, run by Università Vita-Salute San Raffaele at 19 sites in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients requiring Renal Replacement Therapy (time frame: participants will be followed for the duration of intensive care unit stay, an expected average of one week). 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 NCT00621790, which also lists 2 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 14 Oct 2015.