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| Sponsored by: |
Bracco Diagnostics, Inc |
| Information provided by: | Bracco Diagnostics, Inc |
| ClinicalTrials.gov Identifier: | NCT00600951 |
Purpose
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).
| Condition |
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Renal Insufficiency |
| MedlinePlus related topics: | Kidney Failure |
| ChemIDplus related topics: | Gadolinium dtpa |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| 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 |
fixed tissue samples
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|
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)
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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)
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Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
Inclusion Criteria:
COHORT 1
OR
COHORT 2
Exclusion Criteria:
COHORT 1
OR
COHORT 2
Contacts and Locations| Contact: Kathleen Bensel, BS, CNMT | 609-514-2286 | kathleen.bensel@diag.bracco.com |
| United States, New Jersey | |||||
| Bracco Diagnostics Inc. | Recruiting | ||||
| Princeton, New Jersey, United States, 08543 | |||||
| Contact: Gianpaolo Pirovano, MD 609-514-2226 gianpaolo.pirovano@diag.bracco.com | |||||
| Bracco Diagnostics, Inc |
| Study Director: | Gianpaolo Pirovano, MD | Bracco Diagnostics, Inc |
More Information
| Responsible Party: | Gianpaolo Pirovano, MD ( Bracco Diagnostics Inc. ) |
| Study ID Numbers: | MH-136 |
| First Received: | January 14, 2008 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00600951 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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