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Comparison of renal blood flow measurements by PAH clearance and MRI
The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAH | Placebo Comparator | PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide |
|
| MRI after furosemide | Active Comparator | After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Renal Blood Flow of the Kidney by the PAH Method | Renal blood flow is estimated by the PAH method. | Renal blood flow is estimated over 1 hour by PAH |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Regional Blood Oxygenation by MRI | Estimate of renal blood flow by using MRI scans before and after the administration of furosemide | One measure after furosemide (day 1) |
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Inclusion Criteria:
In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.
Exclusion Criteria:
This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rocco, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Furosemide | With and without furosemide Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Furosemide | With and without furosemide Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Renal Blood Flow of the Kidney by the PAH Method | Renal blood flow is estimated by the PAH method. | Posted | Mean | Full Range | ml/min | Renal blood flow is estimated over 1 hour by PAH |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Furosemide | With and without furosemide Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Rocco, MD | Wake Forest School of Medicine | 336-716-4650 | mrocco@wfubmc.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Other |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Measurement of Regional Blood Oxygenation by MRI | Estimate of renal blood flow by using MRI scans before and after the administration of furosemide | Posted | Mean | Full Range | ml/min | One measure after furosemide (day 1) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |