Secondary HyperoxaluriaPhase 2NCT02503345
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
A Phase 2 study testing ALLN-177 low dose, ALLN-177 mid dose and ALLN-177 high dose in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperoxaluria, Nephrolithiasis, Kidney Stones
- What is being tested?
- ALLN-177 low dose, ALLN-177 mid dose and ALLN-177 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2015to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
- Hyperoxaluria at screening
- May be taking drugs for the prevention of stone disease
Who cannot join
- Hyperuricosuria
- Glomerular filtration rate < 55 mL/min/1.73m2
- Hypercalcemia or hypothyroidism
- Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
- Treatment with cholestyramine
- Average daily dietary intake of oxalate <75 mg per day
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Anne Arundel Urology
Annapolis, Maryland, 21401
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brooklyn Urology Research Group
Brooklyn, New York, 11694
Northwestern Feinberg School Of Medicine - Urology Department
Chicago, Illinois, 60611
The Urology Group
Cincinnati, Ohio, 45212
Cleveland Clinic-Urology
Cleveland, Ohio, 44195
UT Southwestern Medical Center - Urology
Dallas, Texas, 75390
Atlantic Urological Associates
Daytona Beach, Florida, 32114
IU Health Physicians Urology
Indianapolis, Indiana, 46202
Mayo Clinic - Nephrology And Hypertension
Jacksonville, Florida, 32224
North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
Lake Success, New York, 11042
Tower Urology
Los Angeles, California, 90048
New York University - Division Of Nephrology
New York, New York, 10016
Mayo Clinic
Rochester, Minnesota, 55902
Urology of Virginia
Virginia Beach, Virginia, 23462
Omega Clinical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.
Eligible subjects will be randomized to 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for up to 60 subjects.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Dietary Hyperoxaluria
- Being tested
- ALLN-177 low dose, ALLN-177 mid dose, ALLN-177 high dose, Placebo
- Keywords
- Kidney Stones, Nephrolithiasis, Urine Oxalate, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Dietary Oxalate
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Hyperoxaluria, Urologic Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLN-177 low doseDrug
Also called Oxalate decarboxylase
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
ALLN-177 mid doseDrug
Also called Oxalate decarboxylase
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
ALLN-177 high doseDrug
Also called Oxalate decarboxylase
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
PlaceboDrug
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules (1, 2 or 5) PO TID Receives: Drug: Placebo |
| ALLN-177 low dose | Experimental | ALLN-177 1,500 units/meal PO TID Receives: Drug: ALLN-177 low dose |
| ALLN-177 mid dose | Experimental | ALLN-177 3,000 units/meal PO TID Receives: Drug: ALLN-177 mid dose |
| ALLN-177 high dose | Experimental | ALLN-177 7,500 units/meal PO TID Receives: Drug: ALLN-177 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean urinary oxalate excretion (mg/24 h) following treatment
Measured: on 7 days of treatment
Secondary outcomes (1)
Change from baseline in mean urinary oxalate excretion (mg/24 h)
Measured: on 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 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, VP Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503345
- Sponsor's protocol ID
- 0000649
- Status last verified
- Jan 2017
- First submitted
- 17 Jul 2015
- Last updated
- 11 Jan 2018
- 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 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
- ClinicalTrials.gov ID
- NCT02503345
- Acronym / sponsor ID
- 0000649
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Dietary Hyperoxaluria
- Keywords
- Kidney Stones, Nephrolithiasis, Urine Oxalate, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Jul 2015 (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 purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
Detailed description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.
Eligible subjects will be randomized to 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for up to 60 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules (1, 2 or 5) PO TID |
| ALLN-177 low dose | Experimental | Drug: ALLN-177 low doseALLN-177 1,500 units/meal PO TID |
| ALLN-177 mid dose | Experimental | Drug: ALLN-177 mid doseALLN-177 3,000 units/meal PO TID |
| ALLN-177 high dose | Experimental | Drug: ALLN-177 high doseALLN-177 7,500 units/meal PO TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
- Hyperoxaluria at screening
- May be taking drugs for the prevention of stone disease
Key exclusion criteria (6 listed)
- Hyperuricosuria
- Glomerular filtration rate < 55 mL/min/1.73m2
- Hypercalcemia or hypothyroidism
- Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
- Treatment with cholestyramine
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-177 low doseAlso: Oxalate decarboxylaseALLN-177 1,500 units (1 capsule)/meal PO 3 times per day | Drug | ALLN-177 low dose |
| ALLN-177 mid doseAlso: Oxalate decarboxylaseALLN-177 3,000 units (2 capsules)/meal PO 3 times per day | Drug | ALLN-177 mid dose |
| ALLN-177 high doseAlso: Oxalate decarboxylaseALLN-177 7,500 units (5 capsules)/meal PO 3 times per day | Drug | ALLN-177 high dose |
| PlaceboPlacebo: 1, 2 or 5 capsules with meals PO 3 times per day | Drug | Placebo |
Primary outcome
Mean urinary oxalate excretion (mg/24 h) following treatment
Time frame: on 7 days of treatment
1 secondary outcome
Change from baseline in mean urinary oxalate excretion (mg/24 h)
Time frame: on 7 days 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 11 Jan 2018.
- 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
VP Clinical Development
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLN-177 low dose, ALLN-177 mid dose and ALLN-177 high dose in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 16 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 3 inclusion and 6 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. Some participants in this study may receive a placebo. 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?
Mean urinary oxalate excretion (mg/24 h) following treatment (time frame: on 7 days 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 11 Jan 2018.