Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

NCT ID: NCT02289755

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-02-28

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.

Detailed Description

A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Conditions

Hyperoxaluria; Nephrolithiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALLN-177

Recurrent 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.

Group Type: EXPERIMENTAL

ALLN-177

Intervention Type: DRUG

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.

Interventions

ALLN-177

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.

Intervention Type: DRUG

Other Intervention Names

Oxalate degrading enzyme; Oxalate decarboxylase

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allena Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Brettman, MD, FACP

Role: STUDY_DIRECTOR

Medical Director

Locations

Indiana University Physicians Urology

Indianapolis, Indiana, United States

North Shore Long Island Jewish Health System

Lake Success, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Omega Clinical Research

Warwick, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30783888 (View on PubMed)

Other Identifiers

0000396

Identifier Type: -

Identifier Source: org_study_id