Acute Kidney FailurePhase 3ACTNCT00736866
The Acetylcysteine for Contrast-Induced Nephropathy Trial
A Phase 3 study testing Acetylcysteine in people with Acute Kidney Failure, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast. Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,300 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of the following criteria:
- Aged more than 70 years-old
- Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
- Diabetes mellitus
- Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
- Shock or intra-aortic balloon pump use
- Urgency or emergency procedures
Who cannot join
- Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
- Patients in dialysis
- Previous inclusion in this trial
- Patient refusal to informed consent
- Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy
The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
- Conditions
- Acute Kidney Failure
- Being tested
- Acetylcysteine, Placebo
- Keywords
- acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent
- 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.
AcetylcysteineDrug
Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
PlaceboDrug
Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
| Study group | Role | What they receive |
|---|---|---|
| Acetylcysteine | Experimental | Not described Receives: Drug: Acetylcysteine |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced nephropathy incidence
Measured: between 48 and 96 hours after angiographic procedures
Secondary outcomes (3)
Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication
Measured: within 30 days
Combined outcome of total mortality or dialysis indication
Measured: within 30 days
The individual components of the combined outcome
Measured: within 30 dias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Medley Pharmaceutical Industry SA
- Investigators
- Eduardo Sousa, PhD, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736866
- Sponsor's protocol ID
- IEP- HCor 001/08
- Acronym
- ACT
- Status last verified
- Aug 2008
- First submitted
- 14 Aug 2008
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9.
PubMed 23572490ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22.
PubMed 21859972ACT Trial Investigators. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.
PubMed 19497091
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy
- ClinicalTrials.gov ID
- NCT00736866
- Acronym / sponsor ID
- ACT / IEP- HCor 001/08
- Conditions
- Acute Kidney Failure
- Keywords
- acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Medley Pharmaceutical Industry SA
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Aug 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.
The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylcysteine | Experimental | Drug: Acetylcysteine |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged more than 70 years-old
- Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
- Diabetes mellitus
- Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
- Shock or intra-aortic balloon pump use
Key exclusion criteria (5 listed)
- Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
- Patients in dialysis
- Previous inclusion in this trial
- Patient refusal to informed consent
- Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.
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 |
|---|---|---|
| AcetylcysteineAcetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography. | Drug | Acetylcysteine |
| PlaceboPlacebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography. | Drug | Control |
Primary outcome
Contrast-induced nephropathy incidence
Time frame: between 48 and 96 hours after angiographic procedures
3 secondary outcomes
Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication
Time frame: within 30 days
Combined outcome of total mortality or dialysis indication
Time frame: within 30 days
The individual components of the combined outcome
Time frame: within 30 dias
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 12 Jul 2010.
- Derived from this study: PubMed 23572490Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9.
- Derived from this study: PubMed 21859972ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22.
- Derived from this study: PubMed 19497091ACT Trial Investigators. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.
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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.
Eduardo Sousa, PhD principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylcysteine in people with Acute Kidney Failure, run by Hospital do Coracao at 1 site in Brazil.
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 7 inclusion and 5 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 12 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Contrast-induced nephropathy incidence (time frame: between 48 and 96 hours after angiographic procedures). 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 NCT00736866, which also lists 3 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 12 Jul 2010.