Enteric HyperoxaluriaPhase 3URIROX-2NCT03847090
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
A Phase 3 study testing Reloxaliase in people with Enteric Hyperoxaluria, run by Allena Pharmaceuticals at 113 sites in 16 countries.
Trial summary
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase 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?
- Reloxaliase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 113 sitesin 16 countries
- Study dates
- 26 Aug 2019to 19 May 2022
- 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 years or older
- Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
- Urinary oxalate ≥ 50 mg/24 hr
- Has at least 1 documented kidney stone within 2 years
Who cannot join
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
- Has a known genetic, congenital, or other cause of kidney stones
- Unable or unwilling to discontinue Vitamin C supplementation >200mg daily
- Cannot establish baseline kidney stone burden
Trial locations and contacts
113 sites in 16 countries.
113 sites in 16 countries
United States64 sites
University of Michigan
Ann Arbor, Michigan, 48084
Accelemed Research Institute
Austin, Texas, 78745
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
University of Alabama- Department of Urology
Birmingham, Alabama, 35234
Brigham and Women's Hospital
Boston, Massachusetts, 02115
IU Health Physicians
Carmel, Indiana, 46032
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, 27599
University of Cincinnati (UC) - Department of Nephrologyv
Cincinnati, Ohio, 45267
University of Missouri Healthcare
Columbia, Missouri, 65211
Ohio State University (OSU)-Renal Division
Columbus, Ohio, 43210
South Florida Nephrology Group PA Research Div
Coral Springs, Florida, 33071
Renal Disease Research Institute
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27516
New York Presbyterian/Queens
Flushing, New York, 11355
University of Florida College of Medicine
Gainesville, Florida, 32610
Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates
Glen Burnie, Maryland, 21061
Renal Consultants Medical Group
Granada Hills, California, 91344
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Quantum Clinical Research
Hialeah, Florida, 33012
Houston Metro Urology
Houston, Texas, 77027
Idaho Catalyst Clinical Research
Idaho Falls, Idaho, 83404
Indiana University (IU) Nephrology
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sheldon J. Freedman, MD
Las Vegas, Nevada, 89144
University of Kentucky
Lexington, Kentucky, 40536
Arkansas Urology
Little Rock, Arkansas, 72211
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
University of Wisconsin - Division of Nephrology
Madison, Wisconsin, 53705
Idaho Urologic Institute
Meridian, Idaho, 83642
Aventiv Research Inc.
Mesa, Arizona, 85210
Pro-Care Research Center, Corp
Miami Gardens, Florida, 33014
Clinical Research Solutions- Middleburg Heights
Middleburg Heights, Ohio, 44130
Montana Medical Research, Inc
Missoula, Montana, 59808
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale University School of Medicine
New Haven, Connecticut, 06510
New York University School of Medicine- Langone Medical Center
New York, New York, 10016
Amicis Research
Northridge, California, 91324
Avanza Medical Research Center
Pensacola, Florida, 32503
Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix
Peoria, Arizona, 85381
Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale
Phoenix, Arizona, 85016
Mayo Mercy Hospital
Phoenix, Arizona, 85054
Oregon Health and Science University (OHSU)
Portland, Oregon, 97239
Lifespan Physician Group Minimally Invasive Urology Institute
Providence, Rhode Island, 02916
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
Mayo Clinic- Department of Nephrology Hyperoxaluria Center
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14620
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Urology San Antonio Research
San Antonio, Texas, 78229
University of California, San Diego (UCSD) Health System
San Diego, California, 92103
University of California- San Francisco (UCSF)
San Francisco, California, 94143
Regional Urology
Shreveport, Louisiana, 71106
Stanford University School of Medicine
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33606
Baylor Scott and White Research Institute- Temple
Temple, Texas, 76508
Genito-Urinary Surgeons
Toledo, Ohio, 43606
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Banner University Medical Center
Tucson, Arizona, 85724
Sutter Health- Sacramento
Vacaville, California, 95688
Urology of Virginia
Virginia Beach, Virginia, 23462
Russia6 sites
Clinic of Urology LLC
Penza, 440026
LLC Medsi St Petersburg
Saint Petersburg, 191025
S.M Kirov Military Medical Academy
Saint Petersburg, 194044
Medical Center "Reavita Med StP" LLC
Saint Petersburg, 194354
City Hospital #15
Saint Petersburg, 198205
Saratov State Medical University, n.a. V.I. Razumosky
Saratov, 410054
Romania5 sites
Sana Medical Center
Bucharest, 011025
Institutul Clinic Fundeni
Bucharest, 022328
Spitalul Clinic Universitar de Urgenta Bucuresti
Bucharest, 50098
ClinTrial/County Hospital Caracal
Caracal, 235200
Centru de Diagnostic si Tratament Affidea- Medicina Interna
Constanța, 900590
United Kingdom5 sites
University Hospital of Wales
Cardiff, CF144XW
Darent Valley Hospital
Dartford, DA2-8DA
The Royal Free Hospital
London, NW3 2QG
South Tyneside District Hospital - South Shields
South Shields, NE34 0PL
Wrexham Maelor Hospital
Wrexham, LL13 7TD
Brazil4 sites
Hospital das Clinicas da UFMG
Belo Horizonte, MG-30130-100
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Faculdade de Medicina do ABC
Santo André, Sp-09060-870
Pesquisare Saude
Santo André, SP-09080-110
Canada4 sites
University of Alberta- Division of Urology
Edmonton, Alberta, T6G1Z1
Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Alpha Recherche Clinique
Québec, Quebec, G2J 0C4
Silverado Research Inc
Victoria, British Columbia, V8T2C1
France4 sites
Hopital Beaujon_AP_HP
Clichy, 92110
AP-HM Hospital de la Conception
Marseille, 13385
Hospital Tenon-AP-HP
Paris, 75970
CHRU de Nancy-Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Mexico4 sites
ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza
Chihuahua City, 31000
Clinstile, S.A. de C.V- Col. Roma Norte Delegacion
Cuauhtémoc, 06700
Invesclinic MX
Irapuato, Gto, C.P, 36650
Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares
Mexico City, 11650
Belgium3 sites
UVC Brugmann University Hospital- Centre Hospitalier Universitaire
Brussels, 1020
Universite Libre de Bruxelles -Hospital Erasme
Brussels, 1070
University Hospital Gent
Ghent, 90000
Italy3 sites
Azienda USL Toscana Centro-Ospedale Santa Maria Nuova
Florence, 50122
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, 16132
Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, 00168
Spain3 sites
Fundacio Puigvert
Barcelona, 08025
Hospital Universitari de Girona
Girona, 17007
Hospital Universitario Virgen del Rocio
Seville, 41013
Germany2 sites
Charite Universitaetsmedizin- Berlin
Berlin, 10117
Klinikum der Universitaet- Muenche
München, 81377
Portugal2 sites
Hospital Fernando da Fonseca
Amadora, 2720-276
Centro Hospitalar Universitario de Sao Joao
Porto, 4200-319
Switzerland2 sites
Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital
Bern, 3010
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department
Lausanne, CH 1011
About this study
Official title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
Read the detailed description
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.
- Conditions
- Enteric Hyperoxaluria
- Being tested
- Reloxaliase, Placebo
- Keywords
- kidney stone, hyperoxaluria, enteric hyperoxaluria, oxalate, kidney calcification
- 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.
ReloxaliaseDrug
Also called ALLN-177, Oxalate decarboxylase
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
PlaceboDrug
Also called Placebo capsule
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
| Study group | Role | What they receive |
|---|---|---|
| Reloxaliase | Experimental | Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule Receives: Drug: Reloxaliase |
| 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 to 4
Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
Measured: 4 weeks
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo
Measured: up to 48 months
Secondary outcomes (4)
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24
Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment
Measured: 24 weeks
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 average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Measured: 4 weeks
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones
Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo
Measured: up to 48 months
Change in estimated glomerular filtration rate (eGFR) from baseline
Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start26 Aug 2019
- Primary completion19 May 2022
- Study completion19 May 2022
Why it stopped: Interim Analysis -
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
- 92 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
- NCT03847090
- Sponsor's protocol ID
- ALLN-177-302
- Other IDs
- 2018-000921-29, 2018
- Acronym
- URIROX-2
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2019
- Last updated
- 10 Jun 2022
- 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 27529510Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.
PubMed 30783888
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
- ClinicalTrials.gov ID
- NCT03847090
- Acronym / sponsor ID
- URIROX-2 / ALLN-177-302
- Conditions
- Enteric Hyperoxaluria
- Keywords
- kidney stone, hyperoxaluria, enteric hyperoxaluria, oxalate, kidney calcification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis -
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 20 Feb 2019 (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, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
Detailed description
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits 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 |
|---|---|---|
| Reloxaliase | Experimental | Drug: ReloxaliaseReloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) 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 (5 listed)
- Provided informed consent
- Age 18 years or older
- Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
- Urinary oxalate ≥ 50 mg/24 hr
- Has at least 1 documented kidney stone within 2 years
Key exclusion criteria (4 listed)
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
- Has a known genetic, congenital, or other cause of kidney stones
- Unable or unwilling to discontinue Vitamin C supplementation >200mg daily
- Cannot establish baseline kidney stone burden
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 |
|---|---|---|
| ReloxaliaseAlso: ALLN-177, Oxalate decarboxylaseReloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day | Drug | Reloxaliase |
| PlaceboAlso: Placebo capsulePlacebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day | Drug | placebo |
Primary outcome
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4
Time frame: 4 weeks
Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
Time frame: up to 48 months
Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo
4 secondary outcomes
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24
Time frame: 24 weeks
Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Time frame: 4 weeks
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones
Time frame: up to 48 months
Change in estimated glomerular filtration rate (eGFR) from baseline
Time frame: up to 48 months
Results and safety
The study was stopped early (reason given: Interim Analysis -). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- 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.
- Background: PubMed 30783888Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.
- A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading EnzymeLink provided by the sponsor.
- ALLN-177, oral enzyme therapy for hyperoxaluriaLink provided by the sponsor.
- 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
113 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reloxaliase in people with Enteric Hyperoxaluria, run by Allena Pharmaceuticals at 113 sites in 16 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Russia, Romania, United Kingdom, Brazil and 11 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 was stopped early (reason given: Interim Analysis -). Results are not available in the source record.
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 to 4 (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT03847090, 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 10 Jun 2022.