Subjects with known or suspected renal artery disease MedDRA version: 13.1 Level: PT Classification code 10038378 Term: Renal artery stenosis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following inclusion criteria must be met at the time of screening unless otherwise specified. 1. Male or female subjects, aged = 18 years 2. Known or suspected renal artery disease based on any of the following: a. referred for evaluation of the renal arteries for clinically significant stenosis b. follow-up for a metallic stent in a renal artery c. prior imaging study (CTA) showing = 50% renal artery stenosis (within 60 days prior to consent) If there is inadequate enrollment of subjects with clinically significant disease (based on CTA interpretation made by the investigators) then the enrollment may be restricted to subjects who underwent a CTA (within 60 days prior to consent) or will undergo a CTA (within 7 days prior to the MRA) showing at least moderate disease (= 50%). This would meet the protocol guidelines as described in Section 8.6.2. Note: Any CTA must meet the specifications provided in Section 7.3.4 and will be used as the SoR for this study. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled. 3. Willingness to undergo the routine CE MRA examinations with gadobutrol 4. Willingness and ability to follow directions and complete all study procedures specified in the protocol 5. Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug 6. Written informed consent, including information about the provisions of the Health Insurance Portability and Accountability Act as applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: The following inclusion criteria must be met at the time of screening unless otherwise specified. 1. Male or female subjects, aged = 18 years 2. Known or suspected renal artery disease based on any of the following: a. referred for evaluation of the renal arteries for clinically significant stenosis b. follow-up for a metallic stent in a renal artery c. prior imaging study (CTA) showing = 50% renal artery stenosis (within 60 days prior to consent) If there is inadequate enrollment of subjects with clinically significant disease (based on CTA interpretation made by the investigators) then the enrollment may be restricted to subjects who underwent a CTA (within 60 days prior to consent) or will undergo a CTA (within 7 days prior to the MRA) showing at least moderate disease (= 50%). This would meet the protocol guidelines as described in Section 8.6.2. Note: Any CTA must meet the specifications provided in Section 7.3.4 and will be used as the SoR for this study. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled. 3. Willingness to undergo the routine CE MRA examinations with gadobutrol 4. Willingness and ability to follow directions and complete all study procedures specified in the protocol 5. Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug 6. Written informed consent, including information about the provisions of the Health Insurance Portability and Accountability Act as applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at the time of screening will be excluded: 1. Pregnant or nursing (including pumping for storage and feeding) 2. Received any other investigational product or participation in any other clinical trial within 30 days prior to enrollment in this study 3. Previous enrollment into this study or any other Bayer sponsored study using gadobutrol 4. Contraindication to the MRI examination (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators, or other metallic devices not approved for MRI) 5. Contraindications to the use of Gd-containing contrast agents (including subjects who are suspected for or known to have NSF) 6. History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen including drugs and contrast agents 7. Received any contrast agent within 72 hours prior to the study MRA, or is scheduled to receive any contrast agent within 72 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study) 8. Estimated glomerular filtration rate (eGFR) value < 30 mL/min/1.73 m² derived from a serum creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment. (Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRA should be used. The core lab value should not be used if not available prior to the MRA/CTA). 9. Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period. 10. Known history of severe cardiovascular disease (e.g., acute myocardial infarction [< 14 days], unstable angina, congestive heart failure [New York Heart Association Class IV]) or known long QT syndrome 11. Suspected clinical instability or unpredictability of the clinical course during the study period (e.g., due to previous surgery or acute stroke) 12. Scheduled or potentially expected for the period between the CTA and gadobutrol MRA: a. any procedure that may alter the MRA or CTA interpretation, or b. any interventional or surgical procedure involving the renal or abdominal aorta ;Exclusion criteria: Subjects who meet any of the following criteria at the time of screening will be excluded: 1. Pregnant or nursing (including pumping for storage and feeding) 2. Received any other investigational product or participation in any other clinical trial within 30 days prior to enrollment in this study 3. Previous enrollment into this study or any other Bayer sponsored study using gadobutrol 4. Contraindication to the MRI examination (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators, or other metallic devices not approved for MRI) 5. Contraindications to the use of Gd-containing contrast agents (including subjects who are suspected for or known to have NSF) 6. History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen including drugs and contrast agents 7. Received any contrast agent within 72 hours prior to the study MRA, or is scheduled to receive any contrast agent within 72 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study) 8. Estimated glomerular filtration rate (eGFR) value < 30 mL/min/1.73 m² derived from a serum creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment. (Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRA should be used. The core lab value should not be used if not available prior to the MRA/CTA). 9. Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period. 10. Known history of severe cardiovascular disease (e.g., acute myocardial infarction [< 14 days], unstable angina, congestive heart failure [New York Heart Association Class IV]) or known long QT syndrome 11. Suspected clinical instability or unpredictability of the clinical course during the study period (e.g., due to previous surgery or acute stroke) 12. Scheduled or potentially expected for the period between the CTA and gadobutrol MRA: a. any procedure that may alter the MRA or CTA interpretation, or b. any interventional or surgical procedure involving the renal or abdominal aorta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of gadobutrol-enhanced MRA over 2D-ToF MRA in subjects with known or suspected renal artery disease, as verified by - superiority for structural delineation, - non-inferiority for the detection of clinically significant vascular disease, - non-inferiority for the exclusion of clinically significant vascular disease, - minimum performance for gadobutrol detection of clinically significant vascular disease, and - minimum performance for gadobutrol exclusion of clinically significant vascular disease using CTA as the SoR excluding the first objective, structural delineation. ;Secondary Objective: A further objective of this study is to confirm the safety profile of gadobutrol for this indication. Secondary efficacy assessments will include: - minimum diameter of the segment - location and length of stenotic segment with =50 % stenosis - aneurysmal dilatation - artifacts by type - diagnostic confidence (segmental) - additional imaging studies recommended (example: non contrast MRA, computed tomography, ultrasound, nuclear medicine study).;Primary end point(s): The following five co-primary endpoints are based on the proportion of assessable vascular segments, and the sensitivity and specificity of clinically significant disease: • Superiority in the proportion of assessable segments with gadobutrol-enhanced MRA compared to non-contrast MRA • Non-inferior diagnosis of clinically significant disease based on the sensitivity [= 50% stenosis] on a segmental basis • Non-inferior diagnosis of clinically significant disease based on the specificity [= 50% stenosis] on a segmental basis • The two minimum gadobutrol performance criteria (both sensitivity and specificity should exceed 50%) ;Timepoint(s) of evaluation of this end point: Approximately 15 months after LPLV;Main Objective: The primary objective of this study is to evaluate the efficacy of gadobutrol-enhanced MRA over 2D-ToF MRA in subj | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary efficacy variables will be summarized: - Length of the right and left renal arteries - Narrowest diameter of a segment - Location of stenoses in the proximal segments - Artifacts by type (segmental) - Accessory (duplicate) renal arteries - Aneurysmal dilatation (segmental) - Diagnosis (subject): FMP vs. arteriosclerosis - Diagnostic confidence (segmental) - Additional imaging studies recommended (subject);Timepoint(s) of evaluation of this end point: Approximately 15 months after LPLV;Secondary end point(s): The following secondary efficacy variables will be summarized: - Length of the right and left renal arteries - Narrowest diameter of a segment - Location of stenoses in the proximal segments - Artifacts by type (segmental) - Accessory (duplicate) renal arteries - Aneurysmal dilatation (segmental) - Diagnosis (subject): FMP vs. arteriosclerosis - Diagnostic confidence (segmental) - Additional imaging studies recommended (subject);Timepoint(s) of evaluation of this end point: Approximately 15 months after LPLV | — |
Countries
Argentina, Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Korea, Republic of, Poland, Switzerland, Taiwan, Turkey, United States
Contacts
Public ContactCTP Team / Ref: "EU CTR" / S102 - R;CTP Team / Ref: "EU CTR" / S102 - R ;
Bayer Health Care AG;Bayer Health Care AG
Outcome results
None listed