Enteric HyperoxaluriaPhase 2NCT03391804
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
A Phase 2 study testing ALLN-177 in people with Enteric Hyperoxaluria and Primary Hyperoxaluria, run by Allena Pharmaceuticals at 9 sites in 3 countries.
Trial summary
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
- What is being tested?
- ALLN-177
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 17 Jul 2018to 13 Dec 2019
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed a informed consent form or an assent
- Aged 12 or older with body weight ≥ 35kg
- History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
- In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
- In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
- Patients on dialysis, must be stable for greater than 3 months
Who cannot join
- 1. Unable or unwilling to discontinue Vitamin C supplementation
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States4 sites
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Yale University School of Medicine
New Haven, Connecticut, 06519
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
United Kingdom4 sites
Leeds General Infirmary
Leeds, LS1 3EX
Freeman Hospital
Newcastle, NE7 7 DN
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
Wellcome Trust Clinical Research Facility
Southampton, Hampshire, SO16 6YD
Germany1 site
Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
Berlin, 10117
About this study
Official title: Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Read the detailed description
Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .
Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.
- Conditions
- Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
- Being tested
- ALLN-177
- Keywords
- Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis
- Medical subject headings
- Hyperoxaluria, Primary, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLN-177Drug
Also called Oxalate decarboxylase
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ALLN-177 | Experimental | ALLN-177 7,500 units (2 capsules) Receives: Drug: ALLN-177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma oxalate
Efficacy will be assessed based on change from baseline in plasma oxalate
Measured: on 12 weeks of treatment
Secondary outcomes (1)
Change in 24-hr urinary oxalate excretion
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Measured: on 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start17 Jul 2018
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteric 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Clark, MD, Study director, Allena Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391804
- Sponsor's protocol ID
- ALLN-177-206
- Other IDs
- 2017-003547-38, 2017
- Status last verified
- Feb 2020
- First submitted
- 2 Jan 2018
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
- ClinicalTrials.gov ID
- NCT03391804
- Acronym / sponsor ID
- ALLN-177-206
- Conditions
- Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
- Keywords
- Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 5 Jan 2018 (actual)
- 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.
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Detailed description
Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .
Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLN-177 | Experimental | Drug: ALLN-177ALLN-177 7,500 units (2 capsules) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Signed a informed consent form or an assent
- Aged 12 or older with body weight ≥ 35kg
- History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
- In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
Key exclusion criteria (1 listed)
- 1. Unable or unwilling to discontinue Vitamin C supplementation
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 |
|---|---|---|
| ALLN-177Also: Oxalate decarboxylaseALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks | Drug | ALLN-177 |
Primary outcome
Change in plasma oxalate
Time frame: on 12 weeks of treatment
Efficacy will be assessed based on change from baseline in plasma oxalate
1 secondary outcome
Change in 24-hr urinary oxalate excretion
Time frame: on 12 weeks of treatment
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 30 Dec 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.
David Clark, MD study director
Allena Pharmaceuticals Inc
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLN-177 in people with Enteric Hyperoxaluria and Primary Hyperoxaluria, run by Allena Pharmaceuticals at 9 sites in 3 countries.
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 7 inclusion and 1 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom, Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in plasma oxalate (time frame: on 12 weeks of treatment). 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 30 Dec 2020.