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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00600834 |
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Date of registration:
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15/01/2008 |
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Primary sponsor: |
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Public title:
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Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease
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Scientific title:
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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 |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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1000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00600834 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Gianpaolo Pirovano, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bracco Diagnostics, Inc |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Insufficiency
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Primary Outcome(s)
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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.
[Time Frame: 1, 3, 6, 12, 18 and 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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