In this pilot study, we aim to validate MR-measurement of GFR to gold standard clearance measurements in subjects with a range of different GFRs: namely chronic kidney disease (CKD) patients, hypertensive patients and healthy subjects.
ID
Source
Brief title
Condition
- Other condition
- Nephropathies
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Agreement between GFR as measured with MRI and GFR as measured with inulin
clearance.
Secondary outcome
NA
Background summary
Currently, diagnostic possibilities in nephrology are limited, time-consuming
or invasive. Therefore, there is an urgent need for additional non-invasive
diagnostic tools. Renal functional Magnetic Resonance Imaging (fMRI) is a
promising modality to fulfil this need. In contrast to computed tomography
(CT), MRI is based on magnetic fields and makes no use of radiation. A
validated MR technique to measure renal blood flow (RBF) already exists.
Furthermore, a technique has been developed to measure single kidney glomerular
filtration rate (skGFR) without the use of contrast agents. Of this, the
glomerular filtration rate (GFR) of both kidney*s combined can be derived, a
measure frequently used clinically.
Study objective
In this pilot study, we aim to validate MR-measurement of GFR to gold standard
clearance measurements in subjects with a range of different GFRs: namely
chronic kidney disease (CKD) patients, hypertensive patients and healthy
subjects.
Study design
In all subjects, both an MRI examination consisting of measurement of skGFR and
RBF and clearance measurements will be performed on the same study day.
Study burden and risks
Subjects are subjected to a one hour MRI scan in a clinical MRI scanner. There
are no known risks associated with MRI, beside temporary dizziness and
claustrophobia. No contrast is needed. For clearance measurements, inulin is
used. Risks associated with this agent is negligible. Clearance measurements
can be experienced as demanding due to their duration, the installation of two
intravenous access sites, frequent blood and urine collection and infusions.
Blood will be sampled via one of the two intravenous access sites (in total 33
mL), to prevent the need for repeated venipuncture.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Subject is >= 18 years of age
- Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study;Exclusively for subjects in the CKD group:
- Subject has a GFR of 30-60 ml/min/1.73 m2 ;Exclusively for subjects in the hypertension group:
- Subject has a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg based on average of 3 office blood pressure readings, or a 24-h ambulatory blood pressure of >=140 mmHg systolic and/or >=90 mmHg diastolic; or is on antihypertensive medication
- Subject has no treatable secondary cause of hypertension
- Subject has no medical record of impaired kidney function (as defined by a GFR <60 ml/min/1.73m2);Exclusively for healthy volunteers:
- Subject has no medical record of impaired kidney function (as defined by a GFR <60 ml/min/1.73m2)
- Subject has no medical record of hypertension (as defined by a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90; or the use of antihypertensive medication)
- Subject can be age matched within a range of ±5 years to one or more subjects in the CKD and hypertension groups
Exclusion criteria
- Subject has an allergy or intolerance to any of the agents used in the study
- Subject has any contraindications for MRI according to screening protocol radiology department UMCU
- Subject is pregnant, nursing or planning to be pregnant
- Subject has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements
- Subject refuses to be informed of chance findings possibly relevant to their health
- Subject is currently being treated with drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone);Exclusively for healthy volunteers and hypertensive subjects:
- Subject has no known renal disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61078.041.17 |