Clinical trial NCT00600834: Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease
Official title: A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of ProHance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief summary: The objective of this long term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR \<30).


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.

OR

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.

OR

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.

Primary outcomes:
measure: 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.
timeFrame: 1, 3, 6, 12, 18 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostic Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References: