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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00600951 |
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 |
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 |
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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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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
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 |
Study Director: | Gianpaolo Pirovano, MD | Bracco Diagnostics, Inc |
Responsible Party: | Gianpaolo Pirovano, MD ( Bracco Diagnostics Inc. ) |
Study ID Numbers: | MH-136 |
Study First Received: | January 14, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00600951 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Renal Insufficiency Urologic Diseases Fibrosis Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Nephrogenic Systemic Fibrosis Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |