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Determination of Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001978
Recruitment Status : Terminated (All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data)
First Posted : January 21, 2000
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief 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....


Condition or disease
Kidney Disease Proteinuria Autoimmune / Connective Tissue Diseases

Detailed Description:

The study of various kidney disorders will be facilitated by determinations of true glomerular filtration rate and/or effective renal plasma flow employing inulin or non-radioactive iothalamate and/or 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/or PAH priming doses.

Glomerular filtration rate, effective renal plasma flow and/or 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 one of two plasma clearance methods that do not require urine collections. For one method, 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. For the second method, the decline in plasma concentration of iothalamate will be measured after an intravenous dose of iothalamate.

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Study Type : Observational
Actual Enrollment : 456 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
Actual Study Start Date : October 11, 1989
Actual Primary Completion Date : October 2, 2020
Actual Study Completion Date : October 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
Study Cohort
Selected patients with proteinuria



Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 4-5 hours ]
    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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical and community sample
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001978


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Meryl A Waldman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional Information:
Publications:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00001978    
Other Study ID Numbers: 890152
89-DK-0152
First Posted: January 21, 2000    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Kidney Disease
Kidney Function Tests
Proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Proteinuria
Connective Tissue Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations