Chronic Kidney Disease, Renal Insufficiency
Conditions
Keywords
CKD - Chronic Kidney Disease, GBCA - Gadolinium-based contrast agent, GFR - Glomerular Filtration Rate, MRI - Magnetic Resonance Imaging, NSF - Nephrogenic Systemic Fibrosis, Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.
Brief summary
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
Interventions
DRUGOmniscan
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent. * The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and \<60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration. * The subject agrees to be contacted for follow-up for 24 months.
Exclusion criteria
* Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows: 1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching; 2. eyes - yellow raised spots on whites of eyes; or 3. bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness. * Patients allergic to any GBCA. * Patients with chronic renal disease with a GFR \<30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration. * Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Greater than or equal to 7 days post contrast administration. | Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN. |
Countries
United States
Participant flow
Recruitment details
There were 213 subjects enrolled in this study. Total of 202 subjects evaluated for safety purposes. Total of 153 subjects completed this study. Total of 11 subjects discontinued prior to contrast administration (no contrast media received).
Participants by arm
| Arm | Count |
|---|---|
| Omniscan OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician. | 202 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 37 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Other reasons | 4 |
| Overall Study | Screening failure | 5 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Omniscan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 118 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 12.41 |
| Region of Enrollment Canada | 28 participants |
| Region of Enrollment China | 62 participants |
| Region of Enrollment India | 10 participants |
| Region of Enrollment Spain | 12 participants |
| Region of Enrollment Taiwan | 77 participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 202 |
| serious Total, serious adverse events | 7 / 202 |
Outcome results
Primary
Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.
Time frame: Greater than or equal to 7 days post contrast administration.
Population: Incidence of Nephrogenic Systemic Fibrosis (NSF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omniscan | Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Reporting of NSF and Symptoms | 3.96 percentage of subjects |
| Omniscan | Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Diagnosis of NSF | 0.00 percentage of subjects |
| Omniscan | Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Biopsy confirmed NSF | 0.00 percentage of subjects |