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Completed

NCT Number: NCT00223548

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

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

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Key information

Conditions

Chronic Renal Insufficiency Acute Kidney Injury Chronic Disease Contrast Media Exposition Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Serum Creatinine Concentration Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Nephrology, University of Ulm

Ulm, 89081, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium 2-mercaptoethane sulfonate

Drug

Primary outcomes

  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 outcomes

  1. Need for dialysis after the administration of contrast media.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie

Important dates

Study start
2002
Study completion
2004
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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