MedDataX Logo

Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

NCT ID: NCT03391804

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2019-12-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Enteric Hyperoxaluria Primary Hyperoxaluria Hyperoxalemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oxalate Kidney Stones oxalate nephropathy systemic oxalosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALLN-177

ALLN-177 7,500 units (2 capsules)

Group Type EXPERIMENTAL

ALLN-177

Intervention Type DRUG

ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALLN-177

ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oxalate decarboxylase

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed a informed consent form or an assent
2. Aged 12 or older with body weight ≥ 35kg
3. 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)
4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR \>15 mL/min/1.73m2
5. In patients with enteric hyperoxaluria, eGFR \< 45mL/min/1.73m2 at Screening
6. In patients with enteric hyperoxaluria, plasma oxalate \> 5µmol/L at Screening
7. Patients on dialysis, must be stable for greater than 3 months

Exclusion Criteria

1\. Unable or unwilling to discontinue Vitamin C supplementation
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allena Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Clark, MD

Role: STUDY_DIRECTOR

Allena Pharmaceuticals Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin

Berlin, , Germany

Site Status

Wellcome Trust Clinical Research Facility

Southampton, Hampshire, United Kingdom

Site Status

Royal Preston Hospital

Preston, Lancashire, United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-003547-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALLN-177-206

Identifier Type: -

Identifier Source: org_study_id