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

Primary Purpose

Secondary Hyperoxaluria, Nephrolithiasis, Kidney Stones

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALLN-177 low dose
ALLN-177 mid dose
ALLN-177 high dose
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 Kidney Stones, Nephrolithiasis, Urine Oxalate, Hyperoxaluria, Enteric Hyperoxaluria, Idiopathic Hyperoxaluria, Urological Diseases, Kidney Diseases, Dietary Oxalate

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Tower Urology
  • Atlantic Urological Associates
  • Mayo Clinic - Nephrology And Hypertension
  • Northwestern Feinberg School Of Medicine - Urology Department
  • IU Health Physicians Urology
  • Anne Arundel Urology
  • Massachusetts General Hospital
  • Mayo Clinic
  • Brooklyn Urology Research Group
  • North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
  • New York University - Division Of Nephrology
  • The Urology Group
  • Cleveland Clinic-Urology
  • Omega Clinical Research
  • UT Southwestern Medical Center - Urology
  • Urology of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

ALLN-177 low dose

ALLN-177 mid dose

ALLN-177 high dose

Arm Description

Placebo capsules (1, 2 or 5) PO TID

ALLN-177 1,500 units/meal PO TID

ALLN-177 3,000 units/meal PO TID

ALLN-177 7,500 units/meal PO TID

Outcomes

Primary Outcome Measures

Mean urinary oxalate excretion (mg/24 h) following treatment

Secondary Outcome Measures

Change from baseline in mean urinary oxalate excretion (mg/24 h)

Full Information

First Posted
July 17, 2015
Last Updated
January 9, 2018
Sponsor
Allena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02503345
Brief Title
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. The study allows for up to 60 subjects.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules (1, 2 or 5) PO TID
Arm Title
ALLN-177 low dose
Arm Type
Experimental
Arm Description
ALLN-177 1,500 units/meal PO TID
Arm Title
ALLN-177 mid dose
Arm Type
Experimental
Arm Description
ALLN-177 3,000 units/meal PO TID
Arm Title
ALLN-177 high dose
Arm Type
Experimental
Arm Description
ALLN-177 7,500 units/meal PO TID
Intervention Type
Drug
Intervention Name(s)
ALLN-177 low dose
Other Intervention Name(s)
Oxalate decarboxylase
Intervention Description
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
Intervention Type
Drug
Intervention Name(s)
ALLN-177 mid dose
Other Intervention Name(s)
Oxalate decarboxylase
Intervention Description
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
Intervention Type
Drug
Intervention Name(s)
ALLN-177 high dose
Other Intervention Name(s)
Oxalate decarboxylase
Intervention Description
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
Primary Outcome Measure Information:
Title
Mean urinary oxalate excretion (mg/24 h) following treatment
Time Frame
on 7 days of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in mean urinary oxalate excretion (mg/24 h)
Time Frame
on 7 days of treatment

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 and at least one kidney stone within the past 2 years Hyperoxaluria at screening May be taking drugs for the prevention of stone disease Exclusion Criteria: 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
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
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Mayo Clinic - Nephrology And Hypertension
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern Feinberg School Of Medicine - Urology Department
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
IU Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Anne Arundel Urology
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11694
Country
United States
Facility Name
North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York University - Division Of Nephrology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Cleveland Clinic-Urology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Omega Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
UT Southwestern Medical Center - Urology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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