- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00600951
Evaluation of the Risk of NSF Following MultiHance 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 MultiHance
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08543
- Bracco Diagnostics Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
A total of 1000 patients in 2 cohorts who are going to receive or have received MULTIHANCE 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).
Description
Inclusion Criteria:
COHORT 1
- Is going to receive or has received MULTIHANCE 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 MULTIHANCE injection.
- Provides written informed consent and is willing to comply with protocol requirements.
OR
COHORT 2
- Is going to receive or has received MULTIHANCE 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 MULTIHANCE 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
Patients with moderate chronic kidney disease (stage 3, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)
|
2
Patients with severe chronic kidney disease or kidney failure (stages 4 and 5, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To estimate and compare the incidence of NSF in the two cohorts 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.
Time Frame: 1, 3, 6, 12, 18 and 24 months
|
1, 3, 6, 12, 18 and 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH-136
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Insufficiency
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
CHU de ReimsUnknownChronic Renal InsufficiencyFrance
-
Azienda Sanitaria ASL Avellino 2UnknownChronic Renal InsufficiencyItaly
-
Assistance Publique Hopitaux De MarseilleCompletedChronic Renal InsufficiencyFrance
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)CompletedAcute Renal Failure | Chronic Renal InsufficiencyAustria
-
Novartis PharmaceuticalsCompletedChronic Renal InsufficiencyUnited States
-
Weill Medical College of Cornell UniversityGenentech, Inc.SuspendedChronic Renal InsufficiencyUnited States
-
University of Colorado, DenverNational Jewish HealthActive, not recruitingHeart Transplantation | Chronic Renal InsufficiencyUnited States