Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001978
Status:
TERMINATED
Last Update Posted:
2020-10-08
First Post:
2000-01-20
Brief Title:
Determination of Kidney Function
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Determination of Glomerular Filtration Rate Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All analysis with identifiable specimensdata is complete or site has no identifiers linked to the specimensdata
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The study of various kidney disorders will be facilitated by determinations of true glomerular filtration rate andor effective renal plasma flow employing inulin or non-radioactive iothalamate andor 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 andor PAH priming doses
Glomerular filtration rate effective renal plasma flow andor 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
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 andor PAH priming doses
Glomerular filtration rate effective renal plasma flow andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 89-DK-0152 | None | None | None |