Renal Insufficiency
Conditions
Brief summary
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
Detailed description
All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms
Interventions
None listed
Sponsors
Guerbet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
Exclusion criteria
* Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem | All patients were followed up during 2 years after Dotarem administration. |
Countries
Argentina, Belgium, Colombia, France, Germany, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety Population The safety population included all patients receiving at least one injection of contrast media regardless of the quantity. | 539 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 84 |
| Overall Study | Lost to Follow-up | 83 |
| Overall Study | Other reason | 14 |
| Overall Study | Retraction of patient's consent | 21 |
Baseline characteristics
| Characteristic | Safety Population | — |
|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 12.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Argentina | 2 participants | — |
| Region of Enrollment Belgium | 121 participants | — |
| Region of Enrollment Colombia | 15 participants | — |
| Region of Enrollment France | 23 participants | — |
| Region of Enrollment Germany | 77 participants | — |
| Region of Enrollment Italy | 37 participants | — |
| Region of Enrollment South Korea | 117 participants | — |
| Region of Enrollment Spain | 12 participants | — |
| Region of Enrollment Turkey | 50 participants | — |
| Region of Enrollment United Kingdom | 9 participants | — |
| Region of Enrollment United States | 76 participants | — |
| Sex: Female, Male Female | 224 Participants | — |
| Sex: Female, Male Male | 315 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 539 |
| other Total, other adverse events | 0 / 539 |
| serious Total, serious adverse events | 0 / 539 |
Outcome results
Primary
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
Time frame: All patients were followed up during 2 years after Dotarem administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NSF Population | Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem | 0 Participants |