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:

Collaborator:

Tehran Heart Center

Information provided by (Responsible Party):

Mohammad Reza Khatami, Imam Khomeini Hospital

ClinicalTrials.gov Identifier:

NCT01359345

First received: October 26, 2009

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

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: 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:

Genetic and Rare Diseases Information Center resources: Nephrogenic Systemic Fibrosis

U.S. FDA Resources

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


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: 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
Study First Received:	October 26, 2009
Last Updated:	June 21, 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

ClinicalTrials.gov processed this record on May 25, 2017

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