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Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

Primary Purpose

Nephrogenic Systemic Fibrosis, Renal Failure

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
gadollinum
Sponsored by
Imam Khomeini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Nephrogenic Systemic Fibrosis focused on measuring NSF, ESRD, MRA, MRI, occurrence of NSF, Use of Gadollinum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Renal Failure
  • Use of Gadollinum

Exclusion Criteria:

  • No consent
  • Age under 18

Sites / Locations

  • Tehran Heart Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

The patients with renal failure in whom Gadollinume has being used

Outcomes

Primary Outcome Measures

occurrence of fibrosis

Secondary Outcome Measures

Full Information

First Posted
October 26, 2009
Last Updated
June 21, 2012
Sponsor
Imam Khomeini Hospital
Collaborators
Tehran Heart Center
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1. Study Identification

Unique Protocol Identification Number
NCT01359345
Brief Title
Nephrogenic Systemic Fibrosis With Gadollinum
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Khomeini Hospital
Collaborators
Tehran Heart Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrogenic Systemic Fibrosis, Renal Failure
Keywords
NSF, ESRD, MRA, MRI, occurrence of NSF, Use of Gadollinum

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
The patients with renal failure in whom Gadollinume has being used
Intervention Type
Drug
Intervention Name(s)
gadollinum
Intervention Description
use of on injection gadollinum Iv for imaging
Primary Outcome Measure Information:
Title
occurrence of fibrosis
Time Frame
after 2 month of exposure with gadollinum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal Failure Use of Gadollinum Exclusion Criteria: No consent Age under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad R Khatami, MD
Organizational Affiliation
TUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Heart Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Nephrogenic Systemic Fibrosis With Gadollinum

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