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Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

This study is enrolling participants by invitation only.
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: Endpoint Classification: Safety Study
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

Further study details as provided by Imam Khomeini Hospital:

Primary Outcome Measures:
  • occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal Failure
  • Use of Gadollinum

Exclusion Criteria:

  • No consent
  • Age under 18
  Contacts and Locations
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

No publications provided

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
Health Authority: Iran: Ethics Committee

Keywords provided by 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 June 13, 2013