Chronic Kidney Disease Stage 2Phase 3NCT01820195
N-Acetyl Cystein and Contrast Nephropathy
A Phase 3 study testing Oral N-Acetyl Cystein and IV N-Acetyl Cystein in people with Chronic Kidney Disease Stage 2 and Radiographic Contrast Agent Nephropathy, run by Imam Khomeini Hospital at 1 site in Iran.
Trial summary
There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 2, Radiographic Contrast Agent Nephropathy
- What is being tested?
- Oral N-Acetyl Cystein and IV N-Acetyl Cystein
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 549 participants
- Where
- 1 siteIran
- Study dates
- Mar 2013to Nov 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- chronic Kidney disease stage 2-4
- use of nephrotoxins in last week leading to angiography
Who cannot join
- Acute kidney injury
- concomitant use of other nephrotoxins
- need of repeated imaging with contrast in five days after the first surgery
- need for surgery in next five day after the contrast exposure
- need of using nephrotoxins in next five days after contrast exposure
Trial locations and contacts
1 site in 1 country.
Mohammad R Khatami, MD contact
Ebrahim Kassaeian, MD contact
Iran1 site, 1 recruiting
- Recruiting
Tehran Heart Center
Tehran
Mohammad R Khatami, MD, 00982161192659, khatami@hbi.ir
About this study
Official title: The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial
There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other than N-Acetyl Cystein. The investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.
Read the detailed description
Contrast Nephropathy is the third cause of acute kidney injury in hospitalized patients. The morbidity and mortality of this disorder is considerable. There is no treatment for this condition and all measures should be taken into account to prevent this complication. Among the all prophylactic measures hydration and the dose ant type of contrast are the only factors that have been proved to be effective in preventing contrast nephropathy. N-Acetyl Cystein is an antioxidant agents that may be effective in different aspects of medicine, but it,s use in this condition is controversial. While some studies showed it is effective in prevention of contrast nephropathy, others showed no benefit. Different studies used different dose and route of administration. So more clinical trials with good power are needed to compare different oral Vs IV administration of the drug in a randomized double blinded clinical trial. In this study we allocate the eligible patients with chronic kidney diseases stages 2 to 4 to three groups. Oral N-Acetyl Cystein group, IV N-Acetyl Cystein group, placebo group. All group will be matched according to stages of chronic kidney diseases, diabetes, anemia, heart failure, age and sex.
- Being tested
- Oral N-Acetyl Cystein, IV N-Acetyl Cystein, Placebo group
- Keywords
- Contrast Nephropathy, N-Acetyl Cystein, Prophylaxy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral N-Acetyl CysteinDrug
Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast
IV N-Acetyl CysteinDrug
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
Placebo groupDrug
The patients in this group will be received both oral placebo and IV placebo
| Study group | Role | What they receive |
|---|---|---|
| Intravenous N Acetyl Cystein | Active comparator | 1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo Receives: Drug: IV N-Acetyl Cystein |
| Placebo | Placebo comparator | Patients on both oral placebo and IV placebo just like patients on oral and IV N-acetyl cystein groups in regard of dose and timing. Receives: Drug: Placebo group |
| Oral N Acetyl Cystein | Active comparator | Patients on 600 mg oral N-Acetyl Cystein bid started at the day before contrast exposure and continue until the next day of contrast exposure.These patients will also take IV placebo Receives: Drug: Oral N-Acetyl Cystein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in serum creatinine more than 25% of baseline
Measured: 24 hours, 48 hours after exposure to contrast media
Secondary outcomes (1)
Increase in serum creatinine more than 25% of baseline
Measured: The 5th day after exposure to contrast media
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 2Studies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 549 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Khomeini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran Heart Center
- Responsible party
- Principal investigator, Mohammad Reza Khatami, Imam Khomeini Hospital
- Investigators
- Mohammad R Khatami, MD, Study chair, Nephrology Research CenterEbrahin Kassaian, MD, Principal investigator, Tehran Heart CenterMojtaba Salarifar, MD, Principal investigator, Tehran Heart CenterAli Kazemi-Saeid, MD, Principal investigator, Tehran Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820195
- Sponsor's protocol ID
- THC-18043
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01820195
- Acronym / sponsor ID
- THC-18043
- Keywords
- Contrast Nephropathy, N-Acetyl Cystein, Prophylaxy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 549 participants (estimated)
- Lead sponsor
- Imam Khomeini HospitalUniversity, hospital or other
- Collaborators
- Tehran Heart Center
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 28 Mar 2013 (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.
There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other than N-Acetyl Cystein. The investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.
Detailed description
Contrast Nephropathy is the third cause of acute kidney injury in hospitalized patients. The morbidity and mortality of this disorder is considerable. There is no treatment for this condition and all measures should be taken into account to prevent this complication. Among the all prophylactic measures hydration and the dose ant type of contrast are the only factors that have been proved to be effective in preventing contrast nephropathy. N-Acetyl Cystein is an antioxidant agents that may be effective in different aspects of medicine, but it,s use in this condition is controversial. While some studies showed it is effective in prevention of contrast nephropathy, others showed no benefit. Different studies used different dose and route of administration. So more clinical trials with good power are needed to compare different oral Vs IV administration of the drug in a randomized double blinded clinical trial. In this study we allocate the eligible patients with chronic kidney diseases stages 2 to 4 to three groups. Oral N-Acetyl Cystein group, IV N-Acetyl Cystein group, placebo group. All group will be matched according to stages of chronic kidney diseases, diabetes, anemia, heart failure, age and sex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous N Acetyl Cystein | Active comparator | Drug: IV N-Acetyl Cystein1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo |
| Placebo | Placebo comparator | Drug: Placebo groupPatients on both oral placebo and IV placebo just like patients on oral and IV N-acetyl cystein groups in regard of dose and timing. |
| Oral N Acetyl Cystein | Active comparator | Drug: Oral N-Acetyl CysteinPatients on 600 mg oral N-Acetyl Cystein bid started at the day before contrast exposure and continue until the next day of contrast exposure.These patients will also take IV placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18
- chronic Kidney disease stage 2-4
- use of nephrotoxins in last week leading to angiography
Key exclusion criteria (5 listed)
- Acute kidney injury
- concomitant use of other nephrotoxins
- need of repeated imaging with contrast in five days after the first surgery
- need for surgery in next five day after the contrast exposure
- need of using nephrotoxins in next five days after contrast exposure
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-Acetyl CysteinOral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast | Drug | Oral N Acetyl Cystein |
| IV N-Acetyl CysteinBolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration | Drug | Intravenous N Acetyl Cystein |
| Placebo groupThe patients in this group will be received both oral placebo and IV placebo | Drug | Placebo |
Primary outcome
Increase in serum creatinine more than 25% of baseline
Time frame: 24 hours, 48 hours after exposure to contrast media
1 secondary outcome
Increase in serum creatinine more than 25% of baseline
Time frame: The 5th day after exposure to contrast media
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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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.
Mohammad R Khatami, MD contact
Ebrahim Kassaeian, MD contact
Mohammad R Khatami, MD study chair
Nephrology Research Center
Ebrahin Kassaian, MD principal investigator
Tehran Heart Center
Mojtaba Salarifar, MD principal investigator
Tehran Heart Center
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 Oral N-Acetyl Cystein and IV N-Acetyl Cystein in people with Chronic Kidney Disease Stage 2 and Radiographic Contrast Agent Nephropathy, run by Imam Khomeini Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 28 Mar 2013. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad R Khatami, MD (khatamis@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in serum creatinine more than 25% of baseline (time frame: 24 hours, 48 hours after exposure to contrast media). 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 28 Mar 2013.