Evaluation of the Risk of NSF Following ProHance Injectio... | NCT00600834

Studies
Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease

NCT00600834

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

172Actual

Phase

Not provided

Conditions

Renal Insufficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Label	Type	Description	Intervention Names
1		patients with moderate CKD (stage 3, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)
2		patients with severe CKD or kidney failure (stages 4 and 5, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2).

Measure	Description	Time Frame
To estimate and compare the incidence of NSF in the two cohorts defined. The incidence is defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients.		1, 3, 6, 12, 18 and 24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COHORT 1

Is going to receive or has received PROHANCE injection during an MRI examination;
Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
Provides written informed consent and is willing to comply with protocol requirements.

COHORT 2

Is going to receive or has received PROHANCE injection during an MRI examination;
Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
Provides written informed consent and is willing to comply with protocol requirements.

Exclusion Criteria:

COHORT 1

Has received a GBCA within the past 12 months prior to inclusion in this study;
Has unstable kidney function;
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

COHORT 2

Has received a GBCA within the past 12 months prior to inclusion in this study;
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

A total of 1000 patients in 2 cohorts who are going to receive or have received PROHANCE during an MRI examination as part of their routine clinical management. The cohorts are defined as:

COHORT 1-

600 patients of any age, with moderate CKD (stage 3, i.e., with eGFR stably comprised between 30 and 59 mL/min/1.73m2);

COHORT 2-

400 patients of any age, with severe CKD or kidney failure (stages 4 and 5, i.e., with eGFR below 30 mL/min/1.73m2).

Sampling Method

Non-Probability Sample

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications