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The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.
A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLN-177 | Experimental | Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLN-177 | Drug | ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion | Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion | Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100% | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Brettman, MD, FACP | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Physicians Urology | Indianapolis | Indiana | 46202 | United States | ||
| North Shore Long Island Jewish Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30783888 | Derived | Lingeman 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. |
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History of ≥1 calcium oxalate kidney stone within the last 2 years, secondary hyperoxaluria and a mean urinary oxalate of ≥36 mg/day
Subjects (N = 16) were recruited from 3 centers in the United States between August 2014 and December 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALLN-177 | ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period [No Treatment, 3 Days] |
| |||||||||||||
| ALLN-177 Treatment Period [4 Days] |
| |||||||||||||
| Follow up Period [4 Days] |
|
All subjects (N=16) were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALLN-177 | ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion | Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7). | All Participants (N=16) completed treatment and were included in the analysis population. | Posted | Mean | Standard Deviation | mg/day | 7 days |
|
|
Up to 11 days.
Treatment-emergent adverse events = AEs with onset at or after starting study drug through 7 days after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALLN-177 | ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Development | Allena Pharmaceuticals | 617-467-4577 | 314 | akausz@allenapharma.com |
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| ID | Term |
|---|---|
| D006959 | Hyperoxaluria |
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| D014570 | Urologic Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000656256 | reloxaliase |
| C021915 | oxalate decarboxylase |
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|
|
| Lake Success |
| New York |
| 11042 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Omega Clinical Research | Warwick | Rhode Island | 02886 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Glomerular Filtration Rate (GFR) | Mean | Full Range | ml/min/1.73 m^2 |
|
| Concomitant medications | Usual methods for treatment of kidney stones/nephrolithiasis were continued throughout the study. Participants could have been prescribed more than one medication, so the sum of participants would be greater than the population. | Number | participants |
|
| 24-hour Urinary Oxalate | Mean | Standard Deviation | mg/day |
|
|
| Secondary | Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion | Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100% | All Participants (N=16) were included in the analysis. | Posted | Mean | Standard Deviation | percentage change | 7 days |
|
|
|
| 0 |
| 16 |
| 9 |
| 16 |
| Abdominal distension | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedRA 16.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedRA 16.0 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedRA 16.0 | Systematic Assessment |
|
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| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |