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NCT01359345 Clinical Trial

Nephrogenic Systemic Fibrosis With Gadollinum

Renal Failure Clinical Trial

— NSF  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01359345
Other study ID # GADOLLINUM
Secondary ID 6553-30-04-86
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received October 26, 2009
Last updated June 21, 2012
Start date July 2008
Est. completion date August 2012

Study information
Verified date June 2012
Source Imam Khomeini Hospital
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date August 2012
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Renal Failure

- Use of Gadollinum

Exclusion Criteria:

- No consent

- Age under 18

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• gadollinum
use of on injection gadollinum Iv for imaging

Locations
Country Name City State
Iran, Islamic Republic of Tehran Heart Center Tehran

Sponsors (2)
Lead Sponsor Collaborator
Imam Khomeini Hospital Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of fibrosis after 2 month of exposure with gadollinum Yes
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