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Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

Primary Purpose

Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALLN-177
Placebo
Sponsored by
Allena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperoxaluria focused on measuring Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Supersaturation, Dietary Oxalate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of enteric or idiopathic hyperoxaluria or kidney stones
  • Urinary oxalate ≥ 50 mg/24 hours

Exclusion Criteria:

  • Hyperuricosuria
  • Glomerular filtration rate < 45 mL/min/1.73m2
  • Hypercalcemia or hyperthyroidism
  • Autoimmune disorder requiring systemic steroids
  • Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

Sites / Locations

  • Mayo Clinica Arizona
  • Urological Associates of Southern Arizona, PC
  • Applied Research Center of Arkansas, Inc.
  • South Florida Medical Research, LLC
  • Atlantic Urological Associates
  • Clinical Research Center of Florida
  • Idaho Urological Institute
  • IU Health Physicians Urology
  • Regional Urology, LLC
  • Massachusetts General Hospital
  • Mayo Clinic Department of Medicine Clinical Trials Unit
  • Delaware Valley Urology, LLC
  • Premier Medical Group of the Hudson Valley
  • Associated Urologists of North Carolina
  • Coastal Urology
  • Tristate Urologic Services PSC INC. DBA The Urology group
  • Clinical Research Solutions, LLC
  • Omega Medical Research
  • Carolina Urologic Research Center
  • Urology Clinics of North Texas PLLC
  • Urology of Virginia
  • Integrity Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ALLN-177

Arm Description

Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals

Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

Outcomes

Primary Outcome Measures

Mean change in urinary oxalate excretion (mg/24h)

Secondary Outcome Measures

Percent change in urinary oxalate excretion
≥ 7.5 mg/24 hr decrease in urinary oxalate
≥ 10 mg/24 hr decrease in urinary oxalate
Mean change in urinary supersaturation of calcium oxalate
Time-weighted average urinary oxalate excretion (mg/24h)

Full Information

First Posted
September 10, 2015
Last Updated
January 17, 2017
Sponsor
Allena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02547805
Brief Title
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
Official Title
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allena Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.
Detailed Description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract. Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones, Dietary Hyperoxaluria
Keywords
Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Supersaturation, Dietary Oxalate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
Arm Title
ALLN-177
Arm Type
Experimental
Arm Description
Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals
Intervention Type
Drug
Intervention Name(s)
ALLN-177
Other Intervention Name(s)
Oxalate decarboxylase
Intervention Description
ALLN-177 7,500 units (5 capsules) PO TID with meals
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 5 capsules PO TID with meals
Primary Outcome Measure Information:
Title
Mean change in urinary oxalate excretion (mg/24h)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Percent change in urinary oxalate excretion
Time Frame
28 days
Title
≥ 7.5 mg/24 hr decrease in urinary oxalate
Time Frame
28 days
Title
≥ 10 mg/24 hr decrease in urinary oxalate
Time Frame
28 days
Title
Mean change in urinary supersaturation of calcium oxalate
Time Frame
28 days
Title
Time-weighted average urinary oxalate excretion (mg/24h)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of enteric or idiopathic hyperoxaluria or kidney stones Urinary oxalate ≥ 50 mg/24 hours Exclusion Criteria: Hyperuricosuria Glomerular filtration rate < 45 mL/min/1.73m2 Hypercalcemia or hyperthyroidism Autoimmune disorder requiring systemic steroids Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Kausz, MD MS
Organizational Affiliation
VP Clinical Development
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinica Arizona
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Urological Associates of Southern Arizona, PC
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Applied Research Center of Arkansas, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
South Florida Medical Research, LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Idaho Urological Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
IU Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic Department of Medicine Clinical Trials Unit
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
555905
Country
United States
Facility Name
Delaware Valley Urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Coastal Urology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Tristate Urologic Services PSC INC. DBA The Urology group
City
Cincinnati, OH
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Clinical Research Solutions, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Clinics of North Texas PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Integrity Medical Research
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

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