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| Descriptive Information Fields | |||||
| Brief Title † | Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease | ||||
| Official Title † | 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 | ||||
| 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 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR <30). |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| Primary Outcome Measure † | 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 ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Renal Insufficiency | ||||
| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 1000 | ||||
| Start Date † | January 2008 | ||||
| Completion Date | March 2013 | ||||
| Eligibility Criteria † | Inclusion Criteria: COHORT 1
OR COHORT 2
Exclusion Criteria: COHORT 1
OR COHORT 2
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00600951 | ||||
| Organization ID | MH-136 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Bracco Diagnostics, Inc | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bracco Diagnostics, Inc | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | January 14, 2008 | ||||
| Last Updated Date | August 8, 2008 | ||||