Secondary HyperoxaluriaNCT03095885
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
A study testing Test Meal in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 5 sites in United States.
Trial summary
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria
- What is being tested?
- Test Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant and non-lactating females
- History of hyperoxaluria secondary to a known underlying enteric disease (e.g., Crohn's disease, bariatric surgery, and others) or without a known underlying cause (idiopathic), and kidney stones.
- Urinary oxalate ≥ 40 mg of oxalate/24 hr at screening.
- If taking drugs for the prevention of stone disease, including pyridoxine, thiazides (chlorthalidone, hydrochlorothiazide, and indapamide), citrate supplements, and allopurinol, there must have been no changes in these medications for at least one month prior to screening and no changes are anticipated for the duration of the study.
- Able to understand and provide written informed consent.
Who cannot join
- Under or over-collection on screening 24-hour urine collection (mg creatinine/kg body weight outside of gender-specific range).
- Estimated glomerular filtration rate (eGFR) <40 mL/minute/1.73 m^2 or acute renal failure.
- Primary hyperoxaluria.
- Allergy, intolerance, or any other factors limiting ability to consume the study foods or adhere to the study meal schedule.
- Positive pregnancy test during Screening.
- Clinically significant findings (including acute renal colic), an ongoing clinically significant illness requiring changes in management, or any planned medical/surgical procedure during the study.
Show all 9Show fewer
- Malignancy undergoing active therapy; patients in remission on chronic suppressive or maintenance therapies are not excluded.
- Investigational compound within 30 days prior to screening.
- Investigator determined that the subject would not be able to adhere or to complete the study procedures , or could not discontinue Vitamin C supplements, calcium supplements, or other medications that could interfere with oxalate absorption and/or excretion.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Applied Research Center of Arkansas, Inc.
Little Rock, Arkansas, 72212
Regional Urology, LLC
Shreveport, Louisiana, 71106
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741
Urology of Virginia
Virginia Beach, Virginia, 23462
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
Read the detailed description
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).
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
- Being tested
- Test Meal
- Keywords
- Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, urological Diseases, Kidney Diseases, Dietary Oxalate, Idiopathic Hyperoxaluria, Oxalate Absorption
- Medical subject headings
- Nephrolithiasis, Hyperoxaluria, Kidney Calculi, Urologic Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test MealOther
| Study group | Role | What they receive |
|---|---|---|
| Test Meal | Other | controlled oxalate-rich test meal Receives: Other: Test Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours during baseline and test day following oxalate-rich meal
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study startNov 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary HyperoxaluriaStudies of the same condition, open and under way.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annamaria Kausz, MD, MS, Study director, Allena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095885
- Sponsor's protocol ID
- ALLN-177-204
- Status last verified
- Oct 2021
- First submitted
- 20 Mar 2017
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
- ClinicalTrials.gov ID
- NCT03095885
- Acronym / sponsor ID
- ALLN-177-204
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
- Keywords
- Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, urological Diseases, Kidney Diseases, Dietary Oxalate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
Detailed description
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Meal | Other | Other: Test Mealcontrolled oxalate-rich test meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or non-pregnant and non-lactating females
- History of hyperoxaluria secondary to a known underlying enteric disease (e.g., Crohn's disease, bariatric surgery, and others) or without a known underlying cause (idiopathic), and kidney stones.
- Urinary oxalate ≥ 40 mg of oxalate/24 hr at screening.
- If taking drugs for the prevention of stone disease, including pyridoxine, thiazides (chlorthalidone, hydrochlorothiazide, and indapamide), citrate supplements, and allopurinol, there must have been no changes in these medications for at least one month prior to screening and no changes are anticipated for the duration of the study.
- Able to understand and provide written informed consent.
Key exclusion criteria (9 listed)
- Under or over-collection on screening 24-hour urine collection (mg creatinine/kg body weight outside of gender-specific range).
- Estimated glomerular filtration rate (eGFR) <40 mL/minute/1.73 m^2 or acute renal failure.
- Primary hyperoxaluria.
- Allergy, intolerance, or any other factors limiting ability to consume the study foods or adhere to the study meal schedule.
- Positive pregnancy test during Screening.
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 |
|---|---|---|
| Test Meal | Other | Test Meal |
Primary outcome
Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period
Time frame: 24 hours during baseline and test day following oxalate-rich meal
Percent of oxalate absorption normalized by baseline was calculated by 100*[UOx/test - UOx/baseline]/Ox intake from the test meal.
2 secondary outcomes
Percent of Oxalate Absorption By Test Interval
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Annamaria Kausz, MD, MS study director
Allena Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Meal in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 5 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 5 inclusion and 9 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period (time frame: 24 hours during baseline and test day following oxalate-rich meal). 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 28 Oct 2021.