NCT01359345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

October 26, 2009

Last Update Submit

June 21, 2012

Conditions

Nephrogenic Systemic FibrosisRenal Failure

Keywords

NSFESRDMRAMRIoccurrence of NSFUse of Gadollinum

Outcome Measures

Primary Outcomes (1)

  • occurrence of fibrosis

    after 2 month of exposure with gadollinum

Study Arms (1)

A

EXPERIMENTAL

The patients with renal failure in whom Gadollinume has being used

Drug: gadollinum

Interventions

gadollinumDRUG

use of on injection gadollinum Iv for imaging

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal Failure
  • Use of Gadollinum

You may not qualify if:

  • No consent
  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran Heart Center

Tehran, Iran

Location

MeSH Terms

Conditions

Nephrogenic Fibrosing DermopathyRenal InsufficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease Attributes

Study Officials

  • Mohammad R Khatami, MD

    TUMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 26, 2009

First Posted

May 24, 2011

Study Start

July 1, 2008

Primary Completion

May 1, 2011

Study Completion

August 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

IR(1)