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

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00223548
First received: September 14, 2005
Last updated: NA
Last verified: September 2002
History: No changes posted
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223548

Locations
Germany
Division of Nephrology, University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
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

ClinicalTrials.gov 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:
prophylaxis
contrast-induced nephropathy
mesna
acute renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Mesna
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014