Determination of Kidney Function
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Disease
Phase: N/A
Status: Recruiting
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Overall contact:
Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov
Summary
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.
Clinical Details
Official title: Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
Study design: N/A
Detailed description:
The study of various kidney disorders will be facilitated by determinations of true
glomerular filtration rate and effective renal plasma flow employing inulin or
non-radioactive iothalamate and para aminohippurate (PAH), respectively.
Selected patients with proteinuria will be asked to participate in studies of glomerular
capillary wall permselectivity calculated from the fractional clearances of the endogenous
proteins, albumin and IgG and from the fractional clearances of polydisperse neutral dextran
with effective molecular radii ranging from 20-60 angstroms. To achieve this, low molecular
weight dextran will be administered by slow IV injection immediately following the inulin or
iothalamate and PAH priming doses.
Glomerular filtration rate, effective renal plasma flow and glomerular permselectivity can be
measured simultaneously during a standard 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 pre-test hydration, is 4 to 5 hours.
Alternatively, glomerular filtration rate can be measured by a plasma clearance method that
does not require urine collections. A steady-state plasma concentration of iothalamate will
be achieved in ambulatory patients by a 24-hour subcutaneous infusion of iothalamate using an
insulin pump.
Eligibility
Minimum age: 7 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- 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.
Locations and Contacts
Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting
Additional Information
NIH Clinical Center Detailed Web Page
Related publications: 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. 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. Blythe WB. The endogenous creatinine clearance. Am J Kidney Dis. 1982 Nov;2(3):321-3. No abstract available.
Starting date: August 1989
Last updated: July 18, 2008
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