Chronic Kidney DiseaseNCT00158080
Hemofiltration for Contrast-Induced Nephropathy
A study testing hemofiltration in people with Chronic Kidney Disease and Cardiac Catheterization, run by Nara Medical University at 1 site in Japan.
Trial summary
Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Kidney Disease, Cardiac Catheterization
- What is being tested?
- hemofiltration
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with serum creatinine>2.0mg/dl and/or GFR<50ml/min
Who cannot join
- Emergent cardiac catheterization
- Patients on chronic dialysis
- Patients with HYHA>III heart failure
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
First Dept of InternalMedicine, Nara Medical University
Kashihara, Nara, 634-8522
Koji Harada, MD, +81-744-22-3051 ext. 3411, kzharada@naramed-u.ac.jp
About this study
Official title: Prevention of Contrast-Induced Nephropathy by Real-Time Hemofiltration
Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization
- Conditions
- Chronic Kidney Disease, Cardiac Catheterization
- Being tested
- hemofiltration
- 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.
hemofiltrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of contrast-induced acute renal failure, Elevation of serum creatinine
Secondary outcomes (1)
Need for hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Nara Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Yoshihiko Saito, MD, PhD, Study director, Nara Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158080
- Sponsor's protocol ID
- K0001
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Publications
Kashyap AS, Anand KP, Kashyap S. Hemofiltration and the prevention of radiocontrast-agent-induced nephropathy. N Engl J Med. 2004 Feb 19;350(8):836-8; author reply 836-8. No abstract available.
PubMed 14978842
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast-Induced Nephropathy by Real-Time Hemofiltration
- ClinicalTrials.gov ID
- NCT00158080
- Acronym / sponsor ID
- K0001
- Conditions
- Chronic Kidney Disease, Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Nara Medical UniversityUniversity, hospital or other
- First posted
- 12 Sep 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.
Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with serum creatinine>2.0mg/dl and/or GFR<50ml/min
Key exclusion criteria (3 listed)
- Emergent cardiac catheterization
- Patients on chronic dialysis
- Patients with HYHA>III heart failure
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 |
|---|---|---|
| hemofiltration | Procedure or surgery | – |
Primary outcome
Prevention of contrast-induced acute renal failure, Elevation of serum creatinine
1 secondary outcome
Need for hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
- Background: PubMed 14978842Kashyap AS, Anand KP, Kashyap S. Hemofiltration and the prevention of radiocontrast-agent-induced nephropathy. N Engl J Med. 2004 Feb 19;350(8):836-8; author reply 836-8. No abstract available.
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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.
Yoshihiko Saito, MD, PhD study director
Nara Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemofiltration in people with Chronic Kidney Disease and Cardiac Catheterization, run by Nara Medical University at 1 site in Japan.
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 3 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 12 Sep 2005. 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 Japan. 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.
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 Koji Harada, MD (+81-744-22-3051 ext. 3411, kzharada@naramed-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of contrast-induced acute renal failure, Elevation of serum creatinine. 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 NCT00158080, which also lists 1 linked publication.
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 Sep 2005.