Kidney DiseaseNCT00026715
Evaluation of New Test Method to Measure Kidney Function
An observational study of Kidney Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will test the accuracy of a new "Fast GFR" (glomerular filtration rate) test to evaluate kidney function. Accurate assessment of kidney function is important in many clinical situations, including detecting kidney disease early, determining appropriate drug dosages, deciding when to begin dialysis, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Disease
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Jun 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both male and female subjects will be recruited without regard to race or ethnic origin.
- Suspected renal dysfunction based upon:
- Acute renal failure with elevated serum creatinine (at least 50% increase within 24 hours preceding enrollment) without stabilization or recovery, despite optimization of hemodynamic fluid status and correction of any known pharmacologic, pre-renal, or post-renal etiologic factors, or
- Congestive heart failure by clinical criteria (rales, S3, pedal edema on clinical exam), or
- Edema or ascites (by clinical exam), or
- Sepsis or septic physiology (shock or hyperdynamic circulation, suspected sepsis), or
Show all 9Show fewer
- Chronic Renal Failure (creatinine greater than 1.3).
- Patients older than 18 years old who provide their own informed consent.
- Patients younger than 18 but at least 6 years old whose parent or legal guardian can provide informed consent.
Who cannot join
- Inability to cooperate with the study.
- Known allergy to iothalamate or other iodine containing compounds.
- Urinary tract obstruction.
- Pregnant women or lactating mothers.
- Patients in whom vascular access cannot be secured.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: Validation of Fast Methods to Measure Glomerular Filtration Rate
This study will test the accuracy of a new "Fast GFR" (glomerular filtration rate) test to evaluate kidney function. Accurate assessment of kidney function is important in many clinical situations, including detecting kidney disease early, determining appropriate drug dosages, deciding when to begin dialysis, and evaluating heart and kidney organ donors and recipients. The current GFR test is used mostly for research purposes, as it is too costly and complicated for general medical use. Another significant drawback to its use in diagnosing acute kidney failure is the time it takes (3 to 24 hours) to complete, since effective therapy for this condition requires its detection as soon as possible. The Fast GFR, by comparison, takes only 45 minutes.
Patients 6 years old and older with kidney disease or with impaired kidney function caused by abnormal heart function or swelling-from congestive heart failure, severe infections, swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this study. Patients will undergo both the standard and the Fast GFR tests, described below, to evaluate the accuracy of the new test.
Read more
Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the other for collecting blood samples. Baseline blood and urine samples are collected and then 0.5 milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5, 10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is collected at 45 minutes. The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied.
Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at 60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.) Urine is collected at 60, 90, 120, 180 and 240 minutes. The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied.
Read the detailed description
Accurate measurement of renal function is required to detect and treat renal dysfunction. The glomerular filtration rate (GFR) is the most widely used test to measure renal function in research studies. However, current GFR tests are lengthy, costly, and too complicated for general use in clinical settings. At the present time, therapies for acute renal failure are generally unsatisfactory. However, it is likely that effective therapy will need to be given early in the course of acute renal failure. We recently developed a simple Fast intravenous GFR test that can be performed in 45 minutes that may assist in identification of patients with the earliest stages of acute renal failure. This test has been validated in ambulatory adults with chronic renal failure. The current protocol will compare the fast intravenous GFR test to a reference standard subcutaneous GFR method in patients with acute renal failure, sepsis, congestive heart failure, edema, or chronic renal failure.
- Conditions
- Kidney Disease
- Keywords
- Renal Function, Iothalamate
- Medical subject headings
- Kidney Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startJun 2000
- Study completionJun 2002
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
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026715
- Sponsor's protocol ID
- 000148
- Other IDs
- 00-DK-0148
- Status last verified
- Jun 2002
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Perrone RD, Steinman TI, Beck GJ, Skibinski CI, Royal HD, Lawlor M, Hunsicker LG. Utility of radioisotopic filtration markers in chronic renal insufficiency: simultaneous comparison of 125I-iothalamate, 169Yb-DTPA, 99mTc-DTPA, and inulin. The Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1990 Sep;16(3):224-35. doi: 10.1016/s0272-6386(12)81022-5.
PubMed 2205098Levey AS, Greene T, Schluchter MD, Cleary PA, Teschan PE, Lorenz RA, Molitch ME, Mitch WE, Siebert C, Hall PM, et al. Glomerular filtration rate measurements in clinical trials. Modification of Diet in Renal Disease Study Group and the Diabetes Control and Complications Trial Research Group. J Am Soc Nephrol. 1993 Nov;4(5):1159-71. doi: 10.1681/ASN.V451159.
PubMed 8305642Coresh J, Toto RD, Kirk KA, Whelton PK, Massry S, Jones C, Agodoa L, Van Lente F. Creatinine clearance as a measure of GFR in screenees for the African-American Study of Kidney Disease and Hypertension pilot study. Am J Kidney Dis. 1998 Jul;32(1):32-42. doi: 10.1053/ajkd.1998.v32.pm9669421.
PubMed 9669421
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Fast Methods to Measure Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT00026715
- Acronym / sponsor ID
- 000148
- Conditions
- Kidney Disease
- Keywords
- Renal Function, Iothalamate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Jun 2002
- First posted
- 15 Nov 2001 (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.
This study will test the accuracy of a new "Fast GFR" (glomerular filtration rate) test to evaluate kidney function. Accurate assessment of kidney function is important in many clinical situations, including detecting kidney disease early, determining appropriate drug dosages, deciding when to begin dialysis, and evaluating heart and kidney organ donors and recipients. The current GFR test is used mostly for research purposes, as it is too costly and complicated for general medical use. Another significant drawback to its use in diagnosing acute kidney failure is the time it takes (3 to 24 hours) to complete, since effective therapy for this condition requires its detection as soon as possible. The Fast GFR, by comparison, takes only 45 minutes.
Patients 6 years old and older with kidney disease or with impaired kidney function caused by abnormal heart function or swelling-from congestive heart failure, severe infections, swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this study. Patients will undergo both the standard and the Fast GFR tests, described below, to evaluate the accuracy of the new test.
Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the other for collecting blood samples. Baseline blood and urine samples are collected and then 0.5 milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5, 10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is collected at 45 minutes. The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied.
Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at 60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.) Urine is collected at 60, 90, 120, 180 and 240 minutes. The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied.
Detailed description
Accurate measurement of renal function is required to detect and treat renal dysfunction. The glomerular filtration rate (GFR) is the most widely used test to measure renal function in research studies. However, current GFR tests are lengthy, costly, and too complicated for general use in clinical settings. At the present time, therapies for acute renal failure are generally unsatisfactory. However, it is likely that effective therapy will need to be given early in the course of acute renal failure. We recently developed a simple Fast intravenous GFR test that can be performed in 45 minutes that may assist in identification of patients with the earliest stages of acute renal failure. This test has been validated in ambulatory adults with chronic renal failure. The current protocol will compare the fast intravenous GFR test to a reference standard subcutaneous GFR method in patients with acute renal failure, sepsis, congestive heart failure, edema, or chronic renal failure.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Both male and female subjects will be recruited without regard to race or ethnic origin.
- Acute renal failure with elevated serum creatinine (at least 50% increase within 24 hours preceding enrollment) without stabilization or recovery, despite optimization of hemodynamic fluid status and correction of any known pharmacologic, pre-renal, or post-renal etiologic factors, or
- Congestive heart failure by clinical criteria (rales, S3, pedal edema on clinical exam), or
- Edema or ascites (by clinical exam), or
- Sepsis or septic physiology (shock or hyperdynamic circulation, suspected sepsis), or
Key exclusion criteria (5 listed)
- Inability to cooperate with the study.
- Known allergy to iothalamate or other iodine containing compounds.
- Urinary tract obstruction.
- Pregnant women or lactating mothers.
- Patients in whom vascular access cannot be secured.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 2205098Perrone RD, Steinman TI, Beck GJ, Skibinski CI, Royal HD, Lawlor M, Hunsicker LG. Utility of radioisotopic filtration markers in chronic renal insufficiency: simultaneous comparison of 125I-iothalamate, 169Yb-DTPA, 99mTc-DTPA, and inulin. The Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1990 Sep;16(3):224-35. doi: 10.1016/s0272-6386(12)81022-5.
- Background: PubMed 8305642Levey AS, Greene T, Schluchter MD, Cleary PA, Teschan PE, Lorenz RA, Molitch ME, Mitch WE, Siebert C, Hall PM, et al. Glomerular filtration rate measurements in clinical trials. Modification of Diet in Renal Disease Study Group and the Diabetes Control and Complications Trial Research Group. J Am Soc Nephrol. 1993 Nov;4(5):1159-71. doi: 10.1681/ASN.V451159.
- Background: PubMed 9669421Coresh J, Toto RD, Kirk KA, Whelton PK, Massry S, Jones C, Agodoa L, Van Lente F. Creatinine clearance as a measure of GFR in screenees for the African-American Study of Kidney Disease and Hypertension pilot study. Am J Kidney Dis. 1998 Jul;32(1):32-42. doi: 10.1053/ajkd.1998.v32.pm9669421.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 4 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026715, 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 4 Mar 2008.