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

Chronic Renal Insufficiency Clinical Trial

Official title:

MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223548
• Other study ID #: A119/2002
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: October 2002
• Est. completion date: December 2004

Study information

• Verified date: September 2002
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Contrast Media Exposition
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Serum Creatinine Concentration

Intervention

Drug:
• sodium 2-mercaptoethane sulfonate

Locations

Country	Name	City	State
Germany	Division of Nephrology, University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for dialysis after the administration of contrast media.