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

NCT02547805 | Completed Phase 2 DMC

• 1 other identifier: 0000713
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 22

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (5)

• Percent change in urinary oxalate excretion

  28 days

• ≥ 7.5 mg/24 hr decrease in urinary oxalate

  28 days

• ≥ 10 mg/24 hr decrease in urinary oxalate

  28 days

• Mean change in urinary supersaturation of calcium oxalate

  28 days

• Time-weighted average urinary oxalate excretion (mg/24h)

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

ALLN-177

EXPERIMENTAL

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

Drug: ALLN-177

Interventions

ALLN-177 DRUG

ALLN-177 7,500 units (5 capsules) PO TID with meals

Also known as: Oxalate decarboxylase

ALLN-177

Placebo DRUG

Placebo 5 capsules PO TID with meals

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allena Pharmaceuticals: lead

Study Sites (22)

Mayo Clinica Arizona

Pheonix, Arizona, 85054, United States

Location

Urological Associates of Southern Arizona, PC

Tuscon, Arizona, 85741, United States

Location

Applied Research Center of Arkansas, Inc.

Little Rock, Arkansas, 72212, United States

Location

South Florida Medical Research, LLC

Aventura, Florida, 33180, United States

Location

Atlantic Urological Associates

Daytona Beach, Florida, 32114, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Idaho Urological Institute

Meridian, Idaho, 83642, United States

Location

IU Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic Department of Medicine Clinical Trials Unit

Rochester, Minnesota, 555905, United States

Location

Delaware Valley Urology, LLC

Voorhees Township, New Jersey, 08043, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Coastal Urology

Wilmington, North Carolina, 28401, United States

Location

Tristate Urologic Services PSC INC. DBA The Urology group

Cincinnati, OH, Ohio, 45212, United States

Location

Clinical Research Solutions, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Clinics of North Texas PLLC

Dallas, Texas, 75231, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Integrity Medical Research

Mountlake Terrace, Washington, 98043, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Hyperoxaluria; Kidney Calculi; Urologic Diseases; Kidney Diseases

Interventions

reloxaliase; oxalate decarboxylase

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Annamaria Kausz, MD MS

  VP Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)