Chronic Renal InsufficiencyPhase 2NCT00223548
MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
A Phase 2 study testing sodium 2-mercaptoethane sulfonate in people with Chronic Renal Insufficiency and Serum Creatinine Concentration, run by University of Ulm at 1 site in Germany.
Trial summary
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Insufficiency, Serum Creatinine Concentration, Contrast Media Exposition
- What is being tested?
- sodium 2-mercaptoethane sulfonate
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2002to Dec 2004
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable chronic renal insufficiency
- serum creatinine concentration > 1,5 mg/dl
Who cannot join
- Dialyzed patients
- patients with acute renal failure
- received iodinated contrast media within 7 days before study entry
- known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy
Read the detailed description
Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.
The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.
- Being tested
- sodium 2-mercaptoethane sulfonate
- Keywords
- prophylaxis, contrast-induced nephropathy, mesna, acute renal failure
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium 2-mercaptoethane sulfonateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
Secondary outcomes (1)
Need for dialysis after the administration of contrast media.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 106 participants
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Frieder Keller, M.D., Principal investigator, Division of Nephrology, University Hospital UlmFrieder Keller, M.D., Principal investigator, Division of Nephrology, University Hospital of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223548
- Sponsor's protocol ID
- A119/2002
- Status last verified
- Sep 2002
- First submitted
- 14 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
- ClinicalTrials.gov ID
- NCT00223548
- Acronym / sponsor ID
- A119/2002
- Keywords
- prophylaxis, contrast-induced nephropathy, mesna, acute renal failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Dec 2004
- First posted
- 22 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.
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy
Detailed description
Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.
The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable chronic renal insufficiency
- serum creatinine concentration > 1,5 mg/dl
Key exclusion criteria (4 listed)
- Dialyzed patients
- patients with acute renal failure
- received iodinated contrast media within 7 days before study entry
- known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine
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 |
|---|---|---|
| sodium 2-mercaptoethane sulfonate | Drug | – |
Primary outcome
Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
1 secondary outcome
Need for dialysis after the administration of contrast media.
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 22 Sep 2005.
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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.
Frieder Keller, M.D. principal investigator
Division of Nephrology, University Hospital Ulm
Frieder Keller, M.D. principal investigator
Division of Nephrology, University Hospital of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium 2-mercaptoethane sulfonate in people with Chronic Renal Insufficiency and Serum Creatinine Concentration, run by University of Ulm at 1 site in Germany.
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 2 inclusion and 4 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 22 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the 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 22 Sep 2005.