An interventional study of Furosemide and Placebo in Chronic Kidney Disease, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by Wake Forest University · Not applicable, Interventional, and Diagnostic
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
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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.
PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
Other: Placebo
After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Drug: Furosemide
Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Also known as: Lasix
Measurement of Renal Blood Flow of the Kidney by the PAH Method
Renal blood flow is estimated by the PAH method.
Time frame: Renal blood flow is estimated over 1 hour by PAH
Measurement of Regional Blood Oxygenation by MRI
Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
Time frame: One measure after furosemide (day 1)
| Milestone | Furosemide |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Renal blood flow is estimated by the PAH method.
| ml/min | Furosemide |
|---|---|
| Measurement of Renal Blood Flow of the Kidney by the PAH Method | 190 (47 to 342) |
Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
| ml/min | MRI After Furosemide |
|---|---|
| Measurement of Regional Blood Oxygenation by MRI | 300 (69 to 620) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Furosemide | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Furosemide |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Furosemide |
|---|---|
| Female | 6 |
| Male | 4 |
| Region of Enrollment(participants) | Furosemide |
|---|---|
| United States | 10 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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