Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
1 other identifier
interventional
16
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
April 27, 2016
CompletedJune 5, 2019
February 1, 2016
4 months
November 10, 2014
December 16, 2015
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion
7 days
Study Arms (1)
ALLN-177
EXPERIMENTALRecurrent 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Able to provide informed consent
- Able to comply with study procedures
- History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone
- Hyperoxaluria \>36mg of oxalate/24-hr
- May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months
You may not qualify if:
- Uric acid ≥1.5g/24-hr
- Estimated glomerular filtration rate of \< 60 mL/min
- Positive results from drug urine screen
- Requires daily vitamin C (defined as \>10 days of \>300 mg/day)
- Diagnosis of hypercalcemia or hypothyroidism
- Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney.
- Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.
- Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial
- History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.
- Taken investigational compound within 30 days prior to the first day of the study
- Treatment with cholestyramine
- Average daily dietary intake of \<75 mg oxalate per day calculated from diet recalls
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Indiana University Physicians Urology
Indianapolis, Indiana, 46202, United States
North Shore Long Island Jewish Health System
Lake Success, New York, 11042, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Omega Clinical Research
Warwick, Rhode Island, 02886, United States
Related Publications (1)
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.
PMID: 30783888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP of Clinical Development
- Organization
- Allena Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Lee Brettman, MD, FACP
Medical Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 13, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
June 5, 2019
Results First Posted
April 27, 2016
Record last verified: 2016-02