Kidney DiseaseNCT00001978
Determination of Kidney Function
An observational study of Kidney Disease and Proteinuria, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Proteinuria, Autoimmune / Connective Tissue Diseases
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 1989to 2 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary clinical and community sample
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
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....
Read the 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.
- Keywords
- Kidney Disease, Kidney Function Tests, Proteinuria
- Medical subject headings
- Kidney Diseases, Proteinuria, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Selected patients with proteinuria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-5 hours
Secondary outcomes (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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2000 (estimated)
- Study start11 Oct 1989
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Why it stopped: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Meryl A Waldman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001978
- Sponsor's protocol ID
- 890152
- Other IDs
- 89-DK-0152
- Status last verified
- Oct 2020
- First submitted
- 20 Jan 2000
- Last updated
- 8 Oct 2020
- Results posted
- No
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. doi: 10.1038/ki.1985.205.
PubMed 2418254Bauer 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. doi: 10.1016/s0272-6386(82)80091-7.
PubMed 7148824Blythe WB. The endogenous creatinine clearance. Am J Kidney Dis. 1982 Nov;2(3):321-3. doi: 10.1016/s0272-6386(82)80089-9. No abstract available.
PubMed 7148823
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Glomerular Filtration Rate, Effective Renal Plasma Flow and Glomerular Capillary Wall Permselectivity
- ClinicalTrials.gov ID
- NCT00001978
- Acronym / sponsor ID
- 890152
- Keywords
- Kidney Disease, Kidney Function Tests, Proteinuria
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data
- Enrolment
- 456 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 11 Oct 1989 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 21 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –Selected patients with proteinuria |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary clinical and community sample
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Effective renal plasma flow
Results and safety
The study was stopped early (reason given: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 2418254Shemesh 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. doi: 10.1038/ki.1985.205.
- Background: PubMed 7148824Bauer 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. doi: 10.1016/s0272-6386(82)80091-7.
- Background: PubMed 7148823Blythe WB. The endogenous creatinine clearance. Am J Kidney Dis. 1982 Nov;2(3):321-3. doi: 10.1016/s0272-6386(82)80089-9. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryl A Waldman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Proteinuria, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (time frame: 4-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.