An interventional study of Test Meal in Secondary Hyperoxaluria, Nephrolithiasis and Hyperoxaluria, sponsored by Allena Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by Allena Pharmaceuticals · Not applicable, Interventional, and Basic science
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4).
Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal.
Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 22 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Allena Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nephrolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
controlled oxalate-rich test meal
Other: Test Meal
Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period
Percent of oxalate absorption normalized by baseline was calculated by 100\*\[UOx/test - UOx/baseline\]/Ox intake from the test meal.
Time frame: 24 hours during baseline and test day following oxalate-rich meal
Percent of Oxalate Absorption By Test Interval
Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.
Time frame: 0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal
Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval
Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 \* \[UOx/Cr for the test interval - UOx/Cr at Baseline\] / UOx/Cr at Baseline.
Time frame: 24 hours during baseline, 0 to 4 hours post test meal, 0-6 hours post test meal, 6-24 hours post test meal, 0-24 hours post test meal
| Milestone | Test Meal |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
Percent of oxalate absorption normalized by baseline was calculated by 100\*\[UOx/test - UOx/baseline\]/Ox intake from the test meal.
| percentage of oxalate absorption | Test Meal |
|---|---|
| Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period | 2.84 ± 2.36 |
Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.
| percentage of oxalate absorption | Test Meal |
|---|---|
| 0-4 Hours post test meal | 2.11 ± 0.52 |
| 0-6 hours post test meal | 3.55 ± 0.88 |
| 0-24 hours post test meal | 10.83 ± 3.04 |
Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 \* \[UOx/Cr for the test interval - UOx/Cr at Baseline\] / UOx/Cr at Baseline.
| Percentage of change of UOx/Cr | Test Meal |
|---|---|
| 0-4 hours post test meal | 68.17 ± 93.05 |
| 0-6 hours post test meal | 84.73 ± 100.05 |
| 6-24 hours post test meal | 45.39 ± 62 |
| 0-24 hours post test meal | 47.14 ± 64.82 |
Collected over 34 days (adverse events were recorded from the time of informed consent until the last study visit, and the screening period was approximately 30 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Meal | 0/22 (0%) | 0/22 (0%) | 3/22 (13.6%) |
| Event | Test Meal |
|---|---|
| ArthritisMusculoskeletal and connective tissue disorders | 1/22 |
| Trigger fingerMusculoskeletal and connective tissue disorders | 1/22 |
| HeadacheNervous system disorders | 1/22 |
| Age, Continuous(years) | Enrolled Set |
|---|---|
| Mean | 57.3 ± 11.6 |
| Sex: Female, Male(Participants) | Enrolled Set |
|---|---|
| Female | 12 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Enrolled Set |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| BMI (kg/m^2)(kg/m^2) | Enrolled Set |
|---|---|
| Mean | 33.45 ± 8.04 |
| Estimated glomerular filtration rate(mL/minute/1.73 /m^2) | Enrolled Set |
|---|---|
| Mean | 80.7 ± 17.4 |
| Hyperoxaluria Classification(Participants) | Enrolled Set |
|---|---|
| Idiopathic Hyperoxaluria | 17 |
| Enteric Hyperoxaluria | 5 |
| Number of Kidney Stone Episodes at Study Entry(Episodes) | Enrolled Set |
|---|---|
| Mean | 5 ± 5.37 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Jan 2017, 2 months.
Results were first posted in Mar 2020, 3 years 2 months after primary completion.
Of 199 interventional studies with no phase under Kidney Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Allena Pharmaceuticals