Working… Menu

Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

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. 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
Tehran Heart Center
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Renal Failure
  • Use of Gadollinum

Exclusion Criteria:

  • No consent
  • Age under 18

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 identifier (NCT number): NCT01359345

Layout table for location information
Iran, Islamic Republic of
Tehran Heart Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Imam Khomeini Hospital
Tehran Heart Center
Layout table for investigator information
Principal Investigator: Mohammad R Khatami, MD TUMS

Layout table for additonal information
Responsible Party: Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital Identifier: NCT01359345     History of Changes
Other Study ID Numbers: GADOLLINUM
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:
occurrence of NSF
Use of Gadollinum
Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Skin Diseases