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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00600834

Enrollment

172

Registered

2008-01-25

Start date

2008-02-29

Completion date

2013-05-31

Last updated

2014-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results