Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR <30).

Official 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

Conditions
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Renal Insufficiency

Participation Criteria
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Eligibility 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with moderate CKD (stage 3, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2) | |
| 2<br>patients with severe CKD or kidney failure (stages 4 and 5, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1, 3, 6, 12, 18 and 24 months |