Disorder Related to Renal TransplantationPhase 3NCT01403506
Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
A Phase 3 study testing N-acetyl Cysteine in people with Disorder Related to Renal Transplantation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated Lipocalin (NGAL) and Intereleukin 18 (IL18). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- N-acetyl Cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Apr 2011to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient receiving transplantation from living donors
Who cannot join
- having a neoplastic disease
- brain tumor
- having inflammatory diseases in their active phase (SLE)
- an acute infection, meningitis, sepsis
- Sickle Cell Disease
- Pregnancy
Show all 18Show fewer
- Cardio-renal syndrome
- endogenous Cushing's syndrome
- chronic use of cimetidine
- a history of acute pancreatitis in recent months
- Multiple Sclerosis
- cardiac bypass in a recent month
- cirrhosis due to Hepatitis C
- having Alzheimer's disease
- having a untreated major depressive illness or schizophrenia
- Stroke in recent months
- Hyperoxaluria
- sensitivity to sulfonamides
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province
Jamshid Salamzadeh
Mohsen Nafar, MD
About this study
Official title: Phase 3 Study of N-acetyl Cysteine as an Antioxidant and Glutathione Synthesis Inducer on Biomarkers of Delayed Renal Graft Function Including NGAL and IL-18
The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated Lipocalin (NGAL) and Intereleukin 18 (IL18).
Read the detailed description
Kidney transplantation is the best treatment for most patients with end stage renal failure, but limited numbers of suitable kidneys are available for transplantation. So preservation of graft is vital. This necessitates the studies and interventions to improve outcome of renal transplantation surgery.
Delayed Graft Function (DGF) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. DGF is a consequence of ischemic and reperfusion injuries (IRI), and oxygen free radicals have a main role in pathophysiology of DGF. In meta-analysis studies, it has been demonstrated that DGF has a correlation with long and short time graft survival. Despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. Major causes of this problem are the lack of appropriate markers for early diagnosis of DGF and on the other hand lack of appropriate and effective interventions to controll DGF.
Studies have shown that N-Acetyl Cysteine (NAC) can induce GSH synthesis, scavenger of free radicals, and infusion of NAC had similar effects as glutathione.
This is a randomized clinical trial (RCT) on patients who have received kidney transplantation from living donors. Sixty transplanted patients will be randomized into 2 groups. The first group of patients will be treated with NAC 600mg 6 hr before transplantation and two doses of NAC 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. For all patients entered the study, urinary concentrations of IL18 and NGAL will be measured in designated times. Risk factors of DGF will be compared in two groups and effectiveness of NAC in reducing DGF will be determined.
- Being tested
- N-acetyl Cysteine
- Keywords
- kidney transplantation, N-Acetyl Cysteine, living donor, delayed graft function
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl CysteineDrug
Also called Acetylcysteine, ACC 600
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
| Study group | Role | What they receive |
|---|---|---|
| N-Acetyl Cysteine | Active comparator | N-Acetyl Cysteine: receive N-Acetyl Cysteine in addition to standard treatment Receives: Drug: N-acetyl Cysteine |
| standard treatment | No intervention | This group is without N-Acetyl Cysteine : just receives standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation
Measured: 4 and 24 hrs after renal graft
Secondary outcomes (1)
dialysis
Measured: 60 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Jamshid Salamzadeh, PhD, Study director, SBMU School of Pharmacy, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403506
- Sponsor's protocol ID
- 186
- Status last verified
- Jan 2011
- First submitted
- 25 Jul 2011
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of N-acetyl Cysteine as an Antioxidant and Glutathione Synthesis Inducer on Biomarkers of Delayed Renal Graft Function Including NGAL and IL-18
- ClinicalTrials.gov ID
- NCT01403506
- Acronym / sponsor ID
- 186
- Keywords
- kidney transplantation, N-Acetyl Cysteine, living donor, delayed graft function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 27 Jul 2011 (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 investigate the effect of (NAC) N-Acetyl Cysteine on biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated Lipocalin (NGAL) and Intereleukin 18 (IL18).
Detailed description
Kidney transplantation is the best treatment for most patients with end stage renal failure, but limited numbers of suitable kidneys are available for transplantation. So preservation of graft is vital. This necessitates the studies and interventions to improve outcome of renal transplantation surgery.
Delayed Graft Function (DGF) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. DGF is a consequence of ischemic and reperfusion injuries (IRI), and oxygen free radicals have a main role in pathophysiology of DGF. In meta-analysis studies, it has been demonstrated that DGF has a correlation with long and short time graft survival. Despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. Major causes of this problem are the lack of appropriate markers for early diagnosis of DGF and on the other hand lack of appropriate and effective interventions to controll DGF.
Studies have shown that N-Acetyl Cysteine (NAC) can induce GSH synthesis, scavenger of free radicals, and infusion of NAC had similar effects as glutathione.
This is a randomized clinical trial (RCT) on patients who have received kidney transplantation from living donors. Sixty transplanted patients will be randomized into 2 groups. The first group of patients will be treated with NAC 600mg 6 hr before transplantation and two doses of NAC 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. For all patients entered the study, urinary concentrations of IL18 and NGAL will be measured in designated times. Risk factors of DGF will be compared in two groups and effectiveness of NAC in reducing DGF will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetyl Cysteine | Active comparator | Drug: N-acetyl CysteineN-Acetyl Cysteine: receive N-Acetyl Cysteine in addition to standard treatment |
| standard treatment | No intervention | –This group is without N-Acetyl Cysteine : just receives standard treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient receiving transplantation from living donors
Key exclusion criteria (18 listed)
- having a neoplastic disease
- brain tumor
- having inflammatory diseases in their active phase (SLE)
- an acute infection, meningitis, sepsis
- Sickle Cell Disease
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 |
|---|---|---|
| N-acetyl CysteineAlso: Acetylcysteine, ACC 600600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation. | Drug | N-Acetyl Cysteine |
Primary outcome
renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation
Time frame: 4 and 24 hrs after renal graft
1 secondary outcome
dialysis
Time frame: 60 days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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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.
Jamshid Salamzadeh, PhD study director
SBMU School of Pharmacy, Tehran, Iran
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 N-acetyl Cysteine in people with Disorder Related to Renal Transplantation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 18 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 27 Jul 2011. 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 Iran. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamshid Salamzadeh, PhD (00982188662334, j.salamzadeh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation (time frame: 4 and 24 hrs after renal graft). 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 27 Jul 2011.