Enteric HyperoxaluriaPhase 3NCT03456830
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
A Phase 3 study testing ALLN-177 in people with Enteric Hyperoxaluria, run by Allena Pharmaceuticals at 63 sites in 7 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteric 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
- 115 participants
- Where
- 63 sitesin 7 countries
- Study dates
- 21 May 2018to 28 Oct 2019
- Phase
- Phase 3
- 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
- Provided informed consent
- Age 18 or older
- History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- Urinary Oxalate ≥ 50mg/24h
Who cannot join
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation
Trial locations and contacts
63 sites in 7 countries.
63 sites in 7 countries
United States39 sites
TROVARE Clinical Research
Bakersfield, California, 93301
Urology Centers of Alabama
Birmingham, Alabama, 35209
University of Alabama, Department of Urology
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Edmund J. Lewis and Associates
Chicago, Illinois, 60607
Tristate Urologic Services PSI Inc
Cincinnati, Ohio, 45212
North Idaho Urology
Coeur d'Alene, Idaho, 83814
Houston Nephrology Group
Cypress, Texas, 77429
Renal Disease Research Institute
Dallas, Texas, 75246
Advanced Urology Institute
Daytona Beach, Florida, 32114
Duke University Medical Center
Durham, North Carolina, 27710
Chesapeake Urology
Hanover, Maryland, 21076
Houston Metro Urology
Houston, Texas, 77027
IU Health Physicians
Indianapolis, Indiana, 46202
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Center for Advanced GI (CFAGI)
Maitland, Florida, 32751
Idaho Urologic Institue
Meridian, Idaho, 83642
South Medical Research Group, Inc.
Miami, Florida, 33186
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Park Avenue Endocrinology & Nutrition
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
The Urology Center, P.C.
Omaha, Nebraska, 68114
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Advanced Urology Centers of New York
Plainview, New York, 11803
Maine Nephrology Associates
Portland, Maine, 04102
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
Mayo Clinic-Dept. of Nephrology
Rochester, Minnesota, 55905
Pen Bay Medical Center
Rockport, Maine, 04856
University of Utah
Salt Lake City, Utah, 84132
Regional Urology
Shreveport, Louisiana, 71106
Washington University School of Medicine
St Louis, Missouri, 63110
Albert Einstein College of Medicine Montefiore Medical Center
The Bronx, New York, 10461
Genito-Urinary Surgeons
Toledo, Ohio, 43606
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urology of Virginia
Virginia Beach, Virginia, 23462
Coastal Urology
Wilmington, North Carolina, 28401
Germany7 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Universitat Bonn - Zentrum für Kinderheilkunde
Bonn, 53113
Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie
Bonn, 53127
Universitatsklinikum Freiburg, Klinik for Urologie
Freiburg im Breisgau, 79106
Universitaetsklinikum Leipzig
Leipzig, 04103
PSHI GmbH; PFÜTZNER Science & Health Institute GmbH
Mainz, 55128
Universitat Munchen - Großhadern
Munich, 81377
Canada5 sites
University of Alberta, Division of Urology
Edmonton, Alberta, T6G1Z1
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 0A9
Research center of CHU de Québec - Université Laval (CHUL)
Québec, Quebec, G1L 3L5
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4YL
Silverado Research Inc
Victoria, British Columbia, V8T2C1
Spain5 sites
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Complejo Asistencial de León
León, 24008
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario Infanta Sofia
Madrid, 28702
Hospital Universitario Virgen del Rocio
Seville, 41013
Italy4 sites
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, 16132
ASST di Lecco
Lecco, 23800
Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)
Lecco, 23900
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168
United Kingdom2 sites
The Royal Free Hospital
London, NW3 2QG
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Read the detailed description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.
- Conditions
- Enteric Hyperoxaluria
- Being tested
- ALLN-177, Placebo
- Keywords
- Kidney stones, Hyperoxaluria, Enteric hyperoxaluria, Oxalate
- Medical subject headings
- Kidney Calculi, Hyperoxaluria
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), orally, with each meal/snack, 3 to 5 times per day for 28 days
PlaceboDrug
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ALLN-177 | Experimental | ALLN-177 3,750 units per capsule Receives: Drug: ALLN-177 |
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Measured: 4 weeks
Secondary outcomes (1)
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start21 May 2018
- Primary completion30 Sep 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 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 Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456830
- Sponsor's protocol ID
- ALLN-177-301
- Status last verified
- Feb 2020
- First submitted
- 1 Mar 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.
PubMed 27529510Lieske JC, Lingeman JE, Ferraro PM, Wyatt CM, Tosone C, Kausz AT, Knauf F. Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria. NEJM Evid. 2022 Jul;1(7):EVIDoa2100053. doi: 10.1056/EVIDoa2100053. Epub 2022 May 6.
PubMed 38319254
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03456830
- Acronym / sponsor ID
- ALLN-177-301
- Conditions
- Enteric Hyperoxaluria
- Keywords
- Kidney stones, Hyperoxaluria, Enteric hyperoxaluria, Oxalate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 7 Mar 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.
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Detailed description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLN-177 | Experimental | Drug: ALLN-177ALLN-177 3,750 units per capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provided informed consent
- Age 18 or older
- History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- Urinary Oxalate ≥ 50mg/24h
Key exclusion criteria (2 listed)
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- 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), orally, with each meal/snack, 3 to 5 times per day for 28 days | Drug | ALLN-177 |
| PlaceboPlacebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days | Drug | Placebo |
Primary outcome
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Time frame: 4 weeks
Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
1 secondary outcome
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Time frame: 4 weeks
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 27 Feb 2020.
- Background: PubMed 27529510Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.
- Derived from this study: PubMed 38319254Lieske JC, Lingeman JE, Ferraro PM, Wyatt CM, Tosone C, Kausz AT, Knauf F. Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria. NEJM Evid. 2022 Jul;1(7):EVIDoa2100053. doi: 10.1056/EVIDoa2100053. Epub 2022 May 6.
- Individual participant dataSharing planned: No
Related trials for Enteric 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
Allena Pharmaceuticals Inc
63 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALLN-177 in people with Enteric Hyperoxaluria, run by Allena Pharmaceuticals at 63 sites in 7 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 4 inclusion and 2 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Canada, Spain, Italy and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456830, which also lists 2 linked publications.
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 27 Feb 2020.