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MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00223548
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Information provided by:
University of Ulm

Brief Summary:
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Condition or disease Intervention/treatment Phase
Chronic Renal Insufficiency Serum Creatinine Concentration Contrast Media Exposition Drug: sodium 2-mercaptoethane sulfonate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
Study Start Date : October 2002
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Mesna

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Need for dialysis after the administration of contrast media.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • stable chronic renal insufficiency
  • serum creatinine concentration > 1,5 mg/dl

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223548

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Division of Nephrology, University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
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Principal Investigator: Frieder Keller, M.D. Division of Nephrology, University Hospital Ulm
Principal Investigator: Frieder Keller, M.D. Division of Nephrology, University Hospital of Ulm
Layout table for additonal information Identifier: NCT00223548    
Other Study ID Numbers: A119/2002
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2002
Keywords provided by University of Ulm:
contrast-induced nephropathy
acute renal failure
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Protective Agents
Physiological Effects of Drugs