Secondary HyperoxaluriaPhase 2NCT02547805
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
A Phase 2 study testing ALLN-177 in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 22 sites in United States.
Trial summary
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones. 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?
- ALLN-177
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 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 or kidney stones
- Urinary oxalate ≥ 50 mg/24 hours
Who cannot join
- Hyperuricosuria
- Glomerular filtration rate < 45 mL/min/1.73m2
- Hypercalcemia or hyperthyroidism
- Autoimmune disorder requiring systemic steroids
- Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
South Florida Medical Research, LLC
Aventura, Florida, 33180
Massachusetts General Hospital
Boston, Massachusetts, 02114
Tristate Urologic Services PSC INC. DBA The Urology group
Cincinnati, OH, Ohio, 45212
Urology Clinics of North Texas PLLC
Dallas, Texas, 75231
Atlantic Urological Associates
Daytona Beach, Florida, 32114
IU Health Physicians Urology
Indianapolis, Indiana, 46202
Applied Research Center of Arkansas, Inc.
Little Rock, Arkansas, 72212
Idaho Urological Institute
Meridian, Idaho, 83642
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, 44130
Integrity Medical Research
Mountlake Terrace, Washington, 98043
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Mayo Clinica Arizona
Pheonix, Arizona, 85054
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Mayo Clinic Department of Medicine Clinical Trials Unit
Rochester, Minnesota, 555905
Regional Urology, LLC
Shreveport, Louisiana, 71106
Urological Associates of Southern Arizona, PC
Tuscon, Arizona, 85741
Urology of Virginia
Virginia Beach, Virginia, 23462
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, 08043
Omega Medical Research
Warwick, Rhode Island, 02886
Coastal Urology
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and 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 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones, Dietary Hyperoxaluria
- Being tested
- ALLN-177, Placebo
- Keywords
- Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Supersaturation, Dietary Oxalate
- 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.
ALLN-177Drug
Also called Oxalate decarboxylase
ALLN-177 7,500 units (5 capsules) PO TID with meals
PlaceboDrug
Placebo 5 capsules PO TID with meals
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals Receives: Drug: Placebo |
| ALLN-177 | Experimental | Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals Receives: Drug: ALLN-177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in urinary oxalate excretion (mg/24h)
Measured: 28 days
Secondary outcomes (5)
Percent change in urinary oxalate excretion
Measured: 28 days
≥ 7.5 mg/24 hr decrease in urinary oxalate
Measured: 28 days
≥ 10 mg/24 hr decrease in urinary oxalate
Measured: 28 days
Mean change in urinary supersaturation of calcium oxalate
Measured: 28 days
Time-weighted average urinary oxalate excretion (mg/24h)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 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
- NCT02547805
- Sponsor's protocol ID
- 0000713
- Status last verified
- Jan 2017
- First submitted
- 10 Sep 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
- ClinicalTrials.gov ID
- NCT02547805
- Acronym / sponsor ID
- 0000713
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones, Dietary Hyperoxaluria
- Keywords
- Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Sep 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.
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and 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 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFive (5) capsules of placebo by mouth (PO) three times per day (TID) with meals |
| ALLN-177 | Experimental | Drug: ALLN-177Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of enteric or idiopathic hyperoxaluria or kidney stones
- Urinary oxalate ≥ 50 mg/24 hours
Key exclusion criteria (5 listed)
- Hyperuricosuria
- Glomerular filtration rate < 45 mL/min/1.73m2
- Hypercalcemia or hyperthyroidism
- Autoimmune disorder requiring systemic steroids
- Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure
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 (5 capsules) PO TID with meals | Drug | ALLN-177 |
| PlaceboPlacebo 5 capsules PO TID with meals | Drug | Placebo |
Primary outcome
Mean change in urinary oxalate excretion (mg/24h)
Time frame: 28 days
5 secondary outcomes
Percent change in urinary oxalate excretion
Time frame: 28 days
≥ 7.5 mg/24 hr decrease in urinary oxalate
Time frame: 28 days
≥ 10 mg/24 hr decrease in urinary oxalate
Time frame: 28 days
Mean change in urinary supersaturation of calcium oxalate
Time frame: 28 days
Time-weighted average urinary oxalate excretion (mg/24h)
Time frame: 28 days
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 19 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Secondary Hyperoxaluria
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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
22 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 in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Allena Pharmaceuticals at 22 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 5 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 change in urinary oxalate excretion (mg/24h) (time frame: 28 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 19 Jan 2017.