Uric Acid NephrolithiasisIUANNCT02975986
Renal Uptake of Fatty Acids (FFA) in Patients With Idiopathic Uric Acid Nephrolithiasis (IUAN)
A study testing 123I-BMIPP and 99mTc-MAG3 in people with Uric Acid Nephrolithiasis, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
The investigators will test the hypothesis that renal uptake of free (i.e. non-esterified) fatty acids (FFa) is increased in iuan. To accomplish this goal the investigators will measure renal FFa uptake FFa uptake in vivo in patients with iuan and matched non-stone forming subjects via single-photon emission computed… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Uric Acid Nephrolithiasis
- What is being tested?
- 123I-BMIPP and 99mTc-MAG3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2017to Dec 2021
- Phase
- Interventional
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In the IUAN group (N=10), we will include adult subjects with documented IUAN, age > 21 years, either sex, any ethnicity
- In the Control group (N=10), we will include volunteers with no history of stone disease matched for age (within 5 years), gender, ethnicity, BMI (within 10%) and diabetes status
Who cannot join
- Contraindications to SPECT/CT, pregnancy, breastfeeding, chronic renal disease (eGFR < 60 ml/min/1.73m2), proteinuria, genetic diseases of the kidney, inborn defects of lipid metabolism, alcohol abuse, liver disease (patients with highly elevated total bilirubin, elevated liver enzymes AST, ALT and alkaline phosphatase and those with an established liver disease), anemia, and pharmacological treatment with insulin or insulin-sensitizing drugs such as thiazolidinediones (TZD).
- Patients on antidyslipidemic drugs, alkali therapy or allopurinol will be instructed to discontinue these drugs 2 weeks prior to the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern Medical Center - Center for Mineral Metabolism
Dallas, Texas, 75390-8885
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
The investigators will test the hypothesis that renal uptake of free (i.e. non-esterified) fatty acids (FFa) is increased in iuan. To accomplish this goal the investigators will measure renal FFa uptake FFa uptake in vivo in patients with iuan and matched non-stone forming subjects via single-photon emission computed tomography (SPeCT)/CT imaging.
The definitive proof of the hypothesis rests on whether increased renal FFa uptake is demonstrable in humans with iuan.
Read the detailed description
This is a cross-sectional study of patients with iuan and matched non-stone formers to test the hypothesis that renal FFa uptake is increased in iuan, using noninvasive 123i-labeled [MiCRo-SYMBoL]-methyl-p-iodo-phenyl-pentadecanoic acid(123i-BMiPP) SPeCT/CT imaging, an established FFa analog approved for human studies.
Participants will be placed on an instructed controlled metabolic diet (30% fat, 15% protein, 55% carbohydrate, 300 mg cholesterol per day, 400 mg calcium, 800mg phosphorus, 100 meq sodium, with low acid ash content, and 3000 cc distilled water) for 5 days to exclude dietary confounders (3 days as outpatient and the final 2 days as inpatient). On days 4 and 5, two fasting blood samples will be collected for the measurement of CMP, insulin, FFa and two 24-h urine samples will be collected under mineral oil to be analyzed for total volume, pH, Cr, na, K, Ca, Mg, Cl, P, uric acid, nH4+, titratable acidity (Ta), sulfate, HCo3- and citrate. The morning of day 6, patients will undergo dual 123i-BMiPP and 99mTc-MaG3 (99mTc mercaptoacetyltriglycine mertiatide) SPeCT/CT imaging after 12 hrs of fasting. 99mTc-MaG3 (8-10mCi) will be injected intravenously for the flow phase of a standard renal scan which includes dynamic imaging for 2 minutes. an additional 1 minute image will be acquired (the 2-3 minute image on a standard renal scan). acquisition will then stop. immediately afterward 123i-BMiPP (4-5mCi) will be injected intravenously for a 1hour uptake period. after the 1 hour uptake dual isotope (Tc-99m and i-123) SPeCT/CT images of the kidney will be acquired on a clinical Siemens Symbia dual head SPeCT/CT system. The 99mTc-MaG3 flow image data will be used to measure renal plasma flow,12 using the Ge Xeleris renal analysis software package already installed on the clinical SPeCT/CT system. The 123i-BMiPP, a gamma emitter with a half-life of 13.13 hours, is to measure renal 123i-BMiPP (FFa) uptake 13 123i-BMiPP uptake will be corrected for effective renal plasma flow (mL/min) measured with 99mTc-MaG3, using the Ge Xeleris renal analysis software package.
Expected findings: If the hypothesis is correct, the investigators expect increased FFa uptake as measured by 123i-BMiPP SPeCT/CT corrected for renal effective plasma flow in the kidney cortex of iuan patients vs. matched controls.
- Conditions
- Uric Acid Nephrolithiasis
- Being tested
- 123I-BMIPP, 99mTc-MAG3
- Keywords
- Nephrolithiasis, Uric Acid, Fatty Acid
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123I-BMIPPOther
Uptake of radioactive isotope by the kidney
99mTc-MAG3Other
Uptake of radioactive isotope by the kidney
| Study group | Role | What they receive |
|---|---|---|
| Controlled metabolic diet | Other | All study patients will be placed on an instructed controlled metabolic diet. Intervention: Uptake of radioactive isotope by the kidney Radiotracer: 123I-BMIPP, 99mTc-MAG3 Receives: Other: 123I-BMIPP; Other: 99mTc-MAG3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased FFA uptake as measured by 123I-BMIPP SPECT/CT corrected for renal effective plasma flow in the kidney cortex of IUAN patients vs. matched controls
Based on preliminary animal study, we anticipate a mean difference of approximately 26% between IUAN and control non-stone forming subjects, but with a higher CV of 20%. For 80% power (=0.05), will be able to detect at 1.5 standardized effect size (%change/CV) with n=10 per group. Comparisons between IUAN and non-stone former groups will be made with two-sample t-tests or Wilcoxon Rank Sum tests.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uric Acid NephrolithiasisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khashayar Sakhaee, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975986
- Sponsor's protocol ID
- STU 092014-032
- Other IDs
- R01DK081423-07
- Acronym
- IUAN
- Status last verified
- Oct 2020
- First submitted
- 23 Nov 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Uptake of Fatty Acids (FFA) in Patients With Idiopathic Uric Acid Nephrolithiasis (IUAN)
- ClinicalTrials.gov ID
- NCT02975986
- Acronym / sponsor ID
- IUAN / STU 092014-032
- Conditions
- Uric Acid Nephrolithiasis
- Keywords
- Nephrolithiasis, Uric Acid, Fatty Acid
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2017
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Nov 2016 (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.
The investigators will test the hypothesis that renal uptake of free (i.e. non-esterified) fatty acids (FFa) is increased in iuan. To accomplish this goal the investigators will measure renal FFa uptake FFa uptake in vivo in patients with iuan and matched non-stone forming subjects via single-photon emission computed tomography (SPeCT)/CT imaging.
The definitive proof of the hypothesis rests on whether increased renal FFa uptake is demonstrable in humans with iuan.
Detailed description
This is a cross-sectional study of patients with iuan and matched non-stone formers to test the hypothesis that renal FFa uptake is increased in iuan, using noninvasive 123i-labeled [MiCRo-SYMBoL]-methyl-p-iodo-phenyl-pentadecanoic acid(123i-BMiPP) SPeCT/CT imaging, an established FFa analog approved for human studies.
Participants will be placed on an instructed controlled metabolic diet (30% fat, 15% protein, 55% carbohydrate, 300 mg cholesterol per day, 400 mg calcium, 800mg phosphorus, 100 meq sodium, with low acid ash content, and 3000 cc distilled water) for 5 days to exclude dietary confounders (3 days as outpatient and the final 2 days as inpatient). On days 4 and 5, two fasting blood samples will be collected for the measurement of CMP, insulin, FFa and two 24-h urine samples will be collected under mineral oil to be analyzed for total volume, pH, Cr, na, K, Ca, Mg, Cl, P, uric acid, nH4+, titratable acidity (Ta), sulfate, HCo3- and citrate. The morning of day 6, patients will undergo dual 123i-BMiPP and 99mTc-MaG3 (99mTc mercaptoacetyltriglycine mertiatide) SPeCT/CT imaging after 12 hrs of fasting. 99mTc-MaG3 (8-10mCi) will be injected intravenously for the flow phase of a standard renal scan which includes dynamic imaging for 2 minutes. an additional 1 minute image will be acquired (the 2-3 minute image on a standard renal scan). acquisition will then stop. immediately afterward 123i-BMiPP (4-5mCi) will be injected intravenously for a 1hour uptake period. after the 1 hour uptake dual isotope (Tc-99m and i-123) SPeCT/CT images of the kidney will be acquired on a clinical Siemens Symbia dual head SPeCT/CT system. The 99mTc-MaG3 flow image data will be used to measure renal plasma flow,12 using the Ge Xeleris renal analysis software package already installed on the clinical SPeCT/CT system. The 123i-BMiPP, a gamma emitter with a half-life of 13.13 hours, is to measure renal 123i-BMiPP (FFa) uptake 13 123i-BMiPP uptake will be corrected for effective renal plasma flow (mL/min) measured with 99mTc-MaG3, using the Ge Xeleris renal analysis software package.
Expected findings: If the hypothesis is correct, the investigators expect increased FFa uptake as measured by 123i-BMiPP SPeCT/CT corrected for renal effective plasma flow in the kidney cortex of iuan patients vs. matched controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled metabolic diet | Other | Other: 123I-BMIPP, Other: 99mTc-MAG3All study patients will be placed on an instructed controlled metabolic diet. Intervention: Uptake of radioactive isotope by the kidney Radiotracer: 123I-BMIPP, 99mTc-MAG3 |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In the IUAN group (N=10), we will include adult subjects with documented IUAN, age > 21 years, either sex, any ethnicity
- In the Control group (N=10), we will include volunteers with no history of stone disease matched for age (within 5 years), gender, ethnicity, BMI (within 10%) and diabetes status
Key exclusion criteria (2 listed)
- Contraindications to SPECT/CT, pregnancy, breastfeeding, chronic renal disease (eGFR < 60 ml/min/1.73m2), proteinuria, genetic diseases of the kidney, inborn defects of lipid metabolism, alcohol abuse, liver disease (patients with highly elevated total bilirubin, elevated liver enzymes AST, ALT and alkaline phosphatase and those with an established liver disease), anemia, and pharmacological treatment with insulin or insulin-sensitizing drugs such as thiazolidinediones (TZD).
- Patients on antidyslipidemic drugs, alkali therapy or allopurinol will be instructed to discontinue these drugs 2 weeks prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 123I-BMIPPUptake of radioactive isotope by the kidney | Other | Controlled metabolic diet |
| 99mTc-MAG3Uptake of radioactive isotope by the kidney | Other | Controlled metabolic diet |
Primary outcome
Increased FFA uptake as measured by 123I-BMIPP SPECT/CT corrected for renal effective plasma flow in the kidney cortex of IUAN patients vs. matched controls
Time frame: 6 days
Based on preliminary animal study, we anticipate a mean difference of approximately 26% between IUAN and control non-stone forming subjects, but with a higher CV of 20%. For 80% power (=0.05), will be able to detect at 1.5 standardized effect size (%change/CV) with n=10 per group. Comparisons between IUAN and non-stone former groups will be made with two-sample t-tests or Wilcoxon Rank Sum tests.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Khashayar Sakhaee, MD principal investigator
UT Southwestern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 123I-BMIPP and 99mTc-MAG3 in people with Uric Acid Nephrolithiasis, run by University of Texas Southwestern Medical Center at 2 sites 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 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 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Increased FFA uptake as measured by 123I-BMIPP SPECT/CT corrected for renal effective plasma flow in the kidney cortex of IUAN patients vs. matched controls (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.