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Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

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ClinicalTrials.gov Identifier: NCT01359345
Recruitment Status : Unknown
Verified June 2012 by Mohammad Reza Khatami, Imam Khomeini Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 24, 2011
Last Update Posted : June 22, 2012
Sponsor:
Collaborator:
Tehran Heart Center
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital

Study Description
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Brief Summary:

Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used.

The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.


Condition or disease Intervention/treatment Phase
Nephrogenic Systemic Fibrosis Renal Failure Drug: gadollinum Phase 2 Phase 3

Detailed Description:

NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question.

We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in 2003-2008
Study Start Date : July 2008
Actual Primary Completion Date : May 2011
Estimated Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
The patients with renal failure in whom Gadollinume has being used
 Drug: gadollinum
use of on injection gadollinum Iv for imaging


Outcome Measures
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Primary Outcome Measures :
  1. occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal Failure
  • Use of Gadollinum

Exclusion Criteria:

  • No consent
  • Age under 18
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359345


Locations
Iran, Islamic Republic of
Tehran Heart Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Imam Khomeini Hospital
Tehran Heart Center
Investigators
Principal Investigator: Mohammad R Khatami, MD TUMS
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital
ClinicalTrials.gov Identifier: NCT01359345     History of Changes
Other Study ID Numbers: GADOLLINUM
6553-30-04-86
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Mohammad Reza Khatami, Imam Khomeini Hospital:
NSF
ESRD
MRA
 MRI
occurrence of NSF
Use of Gadollinum

Additional relevant MeSH terms:
Fibrosis
Renal Insufficiency
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
 Kidney Diseases
Urologic Diseases
Skin Diseases