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Determination of Kidney Function
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), February 2009
First Received: January 20, 2000   Last Updated: August 24, 2009   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001978
  Purpose

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.


Condition
Kidney Disease

Study Type: Observational
Official Title: Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: August 1989
Estimated Primary Completion Date: August 1991 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001978

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 890152, 89-DK-0152
Study First Received: January 20, 2000
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00001978     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Kidney Function Tests
Effective Renal Blood Flow
Filtration Fraction
99m Tc-DTPA
131 I-Hippuran
Gadolinium-DTPA
Macromolecular Clearance
Albumin
Immunoglobulin
Kidney Disease

Additional relevant MeSH terms:
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on November 30, 2009