MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application - Full Text View

Sponsor:	University of Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00223548

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 II

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:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Mesna

U.S. FDA Resources

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

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:

Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

Mesna
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012