Kidney Disease Clinical Trial
Official title:
Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
Verified date | October 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Much more about kidney disorders can be learned by determining kidney function. This research
proposes to study the kidneys function by several parameters known as glomerular filtration
rate (GFR), Renal Plasma Flow (RPF), and Glomerular Capillary Wall Permselectivity.
The study will select patients suffering from different types of kidney diseases. These
patients will be selected based on the presence of significant amounts of protein in their
urine (proteinuria).
Standard blood and urine tests are often unable to provide completely accurate information
about the kidney. In order for researchers to have a more accurate idea of kidney function,
they will use alternative tests. Test materials (para aminohippurate and inulin) will be
injected into patients veins that provides information based on their filtration through the
kidneys....
Status | Terminated |
Enrollment | 456 |
Est. completion date | October 2, 2020 |
Est. primary completion date | October 2, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years and older |
Eligibility |
- INCLUSION CRITERIA: Ability to provide informed assent to all aspects of the study after full information is provided. An indication to measure kidney function as accurately as possible in the context of an approved clinical protocol within the intramural programs of the National Institutes of Health: - For minor subjects, a clinical indication will be required. - For adult subjects, a clinical and/or research indication will be required. EXCLUSION CRITERIA: Pregnant females or nursing mothers will be excluded from all aspects of this study (at least until the infant is stable on a regimen of formula feeding). Patients will not receive a test material if there is a history of allergy to that material. Patients with a history of bronchial asthma or allergy to iodine-containing contrast material will not receive iothalamate. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Bauer JH, Brooks CS, Burch RN. Clinical appraisal of creatinine clearance as a measurement of glomerular filtration rate. Am J Kidney Dis. 1982 Nov;2(3):337-46. — View Citation
Blythe WB. The endogenous creatinine clearance. Am J Kidney Dis. 1982 Nov;2(3):321-3. — View Citation
Shemesh O, Golbetz H, Kriss JP, Myers BD. Limitations of creatinine as a filtration marker in glomerulopathic patients. Kidney Int. 1985 Nov;28(5):830-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glomerular filtration rate | Glomerular filtration rate, effective renal plasma flow and /or glomerular permselectivity can be measured simultaneously during astandard hydrated urinary clearance study. Timed urine and blood collections will be obtained, typically requiring a total of 60 to 90 minutes. The total test time, including pretest hydration, is 4 to 5 hours. | 4-5 hours | |
Secondary | Effective renal plasma flow | Glomerular filtration rate, effective renal plasma flow and /or glomerular permselectivity can be measured simultaneously during astandard hydrated urinary clearance study. Timed urine and blood collections will be obtained, typically requiring a total of 60 to 90 minutes. The total test time, including pretest hydration, is 4 to 5 hours. |
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