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Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Mohammad Reza Khatami, Imam Khomeini Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359345
First Posted: May 24, 2011
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tehran Heart Center
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital
  Purpose

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 Intervention Phase
Nephrogenic Systemic Fibrosis Renal Failure Drug: gadollinum Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mohammad Reza Khatami, Imam Khomeini Hospital:

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

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: August 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The patients with renal failure in whom Gadollinume has being used
Drug: gadollinum
use of on injection gadollinum Iv for imaging

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

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 Submitted: October 26, 2009
First Posted: May 24, 2011
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