Drug Induced NephrotoxicityPhase 2/3NCT00267384
N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
A Phase 2/3 study testing Oral N-Acetylcysteine in people with Drug Induced Nephrotoxicity, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Drug Induced Nephrotoxicity
- What is being tested?
- Oral N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Sep 2008
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
- Aged between 18 and 90.
- Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
- Signed informed consent.
Who cannot join
- Any known allergy or intolerance to one of the medications in the AG group.
- Any known allergy or intolerance to N-acetylcysteine.
- Any immunosuppressive therapy excluding steroid therapy.
- Pregnancy.
- HIV infection.
- Non-sepsis-related neutropenia.
- An estimated creatinine clearance of less than 30 mL/min.
- Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.
- Conditions
- Drug Induced Nephrotoxicity
- Being tested
- Oral N-Acetylcysteine
- Keywords
- Aminoglycosides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral N-AcetylcysteineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease in glomerular filtration rate (GFR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced NephrotoxicityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Novack, Soroka University Medical Center
- Investigators
- Ohad Etzion, MD, Principal investigator, Internal Medicine Division, Soroka University Medical CenterVictor Novack, MD, PhD, Principal investigator, Internal Medicine Division, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267384
- Sponsor's protocol ID
- sor407205ctil
- Status last verified
- Jun 2012
- First submitted
- 16 Dec 2005
- Last updated
- 20 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT00267384
- Acronym / sponsor ID
- sor407205ctil
- Conditions
- Drug Induced Nephrotoxicity
- Keywords
- Aminoglycosides
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Dec 2005 (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.
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
- Aged between 18 and 90.
- Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Any known allergy or intolerance to one of the medications in the AG group.
- Any known allergy or intolerance to N-acetylcysteine.
- Any immunosuppressive therapy excluding steroid therapy.
- Pregnancy.
- HIV infection.
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 |
|---|---|---|
| Oral N-Acetylcysteine | Drug | – |
Primary outcome
The decrease in glomerular filtration rate (GFR)
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 20 Jun 2012.
Related trials for Drug Induced Nephrotoxicity
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
RecruitingPhase 2
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
Mucositis, Nephrotoxicity
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.
Ohad Etzion, MD principal investigator
Internal Medicine Division, Soroka University Medical Center
Victor Novack, MD, PhD principal investigator
Internal Medicine Division, Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral N-Acetylcysteine in people with Drug Induced Nephrotoxicity, run by Soroka University Medical Center at 1 site in Israel.
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 4 inclusion and 8 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 20 Jun 2012. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The decrease in glomerular filtration rate (GFR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2012.