Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
1 other identifier
interventional
32
1 country
16
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2015
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 11, 2018
January 1, 2017
1.1 years
July 17, 2015
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean urinary oxalate excretion (mg/24 h) following treatment
on 7 days of treatment
Secondary Outcomes (1)
Change from baseline in mean urinary oxalate excretion (mg/24 h)
on 7 days of treatment
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo capsules (1, 2 or 5) PO TID
ALLN-177 low dose
EXPERIMENTALALLN-177 1,500 units/meal PO TID
ALLN-177 mid dose
EXPERIMENTALALLN-177 3,000 units/meal PO TID
ALLN-177 high dose
EXPERIMENTALALLN-177 7,500 units/meal PO TID
Interventions
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
Eligibility Criteria
You may qualify if:
- History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
- Hyperoxaluria at screening
- May be taking drugs for the prevention of stone disease
You may not qualify if:
- Hyperuricosuria
- Glomerular filtration rate \< 55 mL/min/1.73m2
- 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
- Treatment with cholestyramine
- Average daily dietary intake of oxalate \<75 mg per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Tower Urology
Los Angeles, California, 90048, United States
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
Mayo Clinic - Nephrology And Hypertension
Jacksonville, Florida, 32224, United States
Northwestern Feinberg School Of Medicine - Urology Department
Chicago, Illinois, 60611, United States
IU Health Physicians Urology
Indianapolis, Indiana, 46202, United States
Anne Arundel Urology
Annapolis, Maryland, 21401, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11694, United States
North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
Lake Success, New York, 11042, United States
New York University - Division Of Nephrology
New York, New York, 10016, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Cleveland Clinic-Urology
Cleveland, Ohio, 44195, United States
Omega Clinical Research
Warwick, Rhode Island, 02886, United States
UT Southwestern Medical Center - Urology
Dallas, Texas, 75390, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Annamaria Kausz, MD MS
VP Clinical Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 21, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2016
Study Completion
January 1, 2017
Last Updated
January 11, 2018
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share