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

This study has been completed.
Information provided by:
University of Ulm Identifier:
First received: September 14, 2005
Last updated: NA
Last verified: September 2002
History: No changes posted
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie

Resource links provided by NLM:

Further study details as provided by University of Ulm:

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

Estimated Enrollment: 106
Study Start Date: October 2002
Estimated Study Completion Date: December 2004
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00223548

Division of Nephrology, University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
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
  More Information

No publications provided Identifier: NCT00223548     History of Changes
Other Study ID Numbers: A119/2002
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
contrast-induced nephropathy
acute renal failure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents processed this record on November 27, 2015