Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04987294
• Other study ID #: ALLN-346-202
• Status: Terminated
• Phase: Phase 2
• Start date: September 2, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: June 2023
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.

Description:

This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female, age 18 to 70 years
• Serum UA level = 8.0 mg/dL at Screening (hyperuricemia)
• Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
• Screening eGFR of =60 - <90 mL/minute/1.73 m2 for Cohort A and =30 - <60 mL/minute/1.73 m2 for Cohort B.
• Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
• Body Mass Index (BMI) = 18 and = 40 kg/m2, inclusive, at screening
• Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation

Exclusion Criteria:

• Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
• Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
• Gout flare requiring treatment within 14 days prior to or during Screening
• Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
• History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
• Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
• Prior dosing in ALLN-346 clinical study
• Per Investigator judgment, is not an ideal clinical study candidate

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Gout
• Hyperuricemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
• Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Locations

Country	Name	City	State
United States	Orthopedic Physicians Alaska	Anchorage	Alaska
United States	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	NY Total Medical Care, PC	Brooklyn	New York
United States	Best Quality Research, Inc.	Hialeah	Florida
United States	Eastern Research, Inc.	Hialeah	Florida
United States	New Generation of Medical Research	Hialeah	Florida
United States	Elite Clinical Research, LLC	Jackson	Mississippi
United States	P&I Clinical Research, LLC	Lufkin	Texas
United States	Kendall South Medical Center, Inc.	Miami	Florida
United States	Allameh Medical Corporation	Mission Viejo	California
United States	Burke Primary Care	Morganton	North Carolina
United States	Syed Research Consultants, LLC	Muscle Shoals	Alabama
United States	Briggs Clinical Research, LLC	San Antonio	Texas
United States	Syed Research Consultants, LLC	Sheffield	Alabama
United States	Summit research Group, LLC	Stow	Ohio
United States	The Center of Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)	Treatment emergent adverse events	42 days
Secondary	Serum Urate	Serum urate [mg/dL]	14 Days