MESNA for Prevention of Acute Deterioration of Renal Func... | NCT00223548

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

NCT00223548

Sponsor

University of Ulm

Status

Completed

Last Update Posted

Sep 22, 2005Estimated

Enrollment

106

Phase

Phase 2

Conditions

Chronic Renal Insufficiency
Serum Creatinine Concentration
Contrast Media Exposition

Interventions

sodium 2-mercaptoethane sulfonate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2005

Last Update Posted Date

Sep 22, 2005Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106

Name	Type	Description	Arm Group Labels	Other Names
sodium 2-mercaptoethane sulfonate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Need for dialysis after the administration of contrast media.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frieder Keller, M.D.	Division of Nephrology, University Hospital Ulm	Principal Investigator
Frieder Keller, M.D.	Division of Nephrology, University Hospital of Ulm	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Nephrology, University of Ulm		Ulm		89081	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015080	Mesna

Ancestor Terms

ID	Term
D000476	Alkanesulfonates
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided