Chronic Renal FailurePhase 4NCT00716001
Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure
A Phase 4 study testing N-acetylcysteine in people with Chronic Renal Failure, run by Osaka General Medical Center.
Trial summary
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jun 2009
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic renal failure(serum creatinine >1.1mg/dl) undergoing elective percutaneous coronary intervention
Who cannot join
- administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
- pregnancy
- congestive heart failure
- allergy to sodium bicarbonate and/or N-acetylcysteine
- hemodialysis
About this study
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.
- Conditions
- Chronic Renal Failure
- Being tested
- N-acetylcysteine
- Keywords
- patients with chronic renal failure undergoing elective percutaneous coronary intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
| Study group | Role | What they receive |
|---|---|---|
| NAC | Active comparator | Not described Receives: Drug: N-acetylcysteine |
| nonNAC | Placebo comparator | Not described Receives: Drug: N-acetylcysteine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Osaka General Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716001
- Sponsor's protocol ID
- OPTSB
- Status last verified
- Jul 2008
- First submitted
- 2 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure
- ClinicalTrials.gov ID
- NCT00716001
- Acronym / sponsor ID
- OPTSB
- Conditions
- Chronic Renal Failure
- Keywords
- patients with chronic renal failure undergoing elective percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Osaka General Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- First posted
- 15 Jul 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.
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC | Active comparator | Drug: N-acetylcysteine |
| nonNAC | Placebo comparator | Drug: N-acetylcysteine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with chronic renal failure(serum creatinine >1.1mg/dl) undergoing elective percutaneous coronary intervention
Key exclusion criteria (5 listed)
- administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
- pregnancy
- congestive heart failure
- allergy to sodium bicarbonate and/or N-acetylcysteine
- hemodialysis
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-acetylcysteine | Drug | NAC, nonNAC |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2008.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetylcysteine in people with Chronic Renal Failure, run by Osaka General Medical Center.
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 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 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 15 Jul 2008.