Trial record 2 of 2 for:
ALLN-346 | Phase 2
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04987294 |
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Recruitment Status :
Recruiting
First Posted : August 3, 2021
Last Update Posted : December 6, 2021
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Sponsor:
Allena Pharmaceuticals
Information provided by (Responsible Party):
Allena Pharmaceuticals
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperuricemia Gout Chronic Kidney Diseases | Drug: ALLN-346 Drug: Placebo | Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Subjects will be randomized 2:1 to receive ALLN-346 or placebo. |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 31, 2021 |
| Estimated Primary Completion Date : | July 30, 2022 |
| Estimated Study Completion Date : | July 30, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Gout
| Arm | Intervention/treatment |
|---|---|
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Experimental: ALLN-346 (Engineered Urate Oxidase)
ALLN-346 is novel urate oxidase provided as capsules for oral administration. ALLN-346 will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.
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Drug: ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Other Name: Engineered urate oxidase |
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Placebo Comparator: Placebo
Matching placebo capsules for oral administration. Placebo capsules will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.
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Drug: Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other Name: Matching placebo capsule |
Primary Outcome Measures :
- Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 42 days ]Treatment emergent adverse events
Secondary Outcome Measures :
- Serum Urate [ Time Frame: 14 Days ]Serum urate [mg/dL]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04987294
Contacts
| Contact: B Kandinov, PhD | (617) 467-4577 | Clinical346@allenapharma.com |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Stephanie Clark, RN 205-934-1444 sbiggers@uabmc.edu | |
| Syed Research Consultants, LLC | Recruiting |
| Muscle Shoals, Alabama, United States, 35661 | |
| Contact: Loren McCoy, MD | |
| Syed Research Consultants, LLC | Recruiting |
| Sheffield, Alabama, United States, 35660 | |
| Contact: Aaron Karr, MD | |
| United States, Alaska | |
| Orthopedic Physicians Alaska | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Contact: John Botson, MD | |
| United States, California | |
| Allameh Medical Corporation | Recruiting |
| Mission Viejo, California, United States, 92691 | |
| Contact: Reza Azadegan Research@DrAllameh.com | |
| United States, Florida | |
| Eastern Research, Inc. | Recruiting |
| Hialeah, Florida, United States, 33013 | |
| Contact: Ana Martinez easternresearch.am@aol.com | |
| Best Quality Research, Inc. | Recruiting |
| Hialeah, Florida, United States, 33016 | |
| Contact: Rudolfo Gutierrez-Alsina, MD | |
| New Generation of Medical Research | Recruiting |
| Hialeah, Florida, United States, 33016 | |
| Contact: Karelia Ruiz, MD | |
| Kendall South Medical Center, Inc. | Recruiting |
| Miami, Florida, United States, 33185 | |
| Contact: Rafael Chiong, MD | |
| United States, Maryland | |
| The Center of Rheumatology and Bone Research | Recruiting |
| Wheaton, Maryland, United States, 20902 | |
| Contact: Jeffrey A Pottter, MD 301-942-6610 jap.crbr@gmail.com | |
| United States, Mississippi | |
| Elite Clinical Research, LLC | Recruiting |
| Jackson, Mississippi, United States, 39202 | |
| Contact: Christina Barlow, MD | |
| United States, New York | |
| NY Total Medical Care, PC | Recruiting |
| Brooklyn, New York, United States, 11215 | |
| Contact: Jorge Serje, MD | |
| United States, North Carolina | |
| Burke Primary Care | Recruiting |
| Morganton, North Carolina, United States, 28655 | |
| Contact: Stephen Smith, MD | |
| United States, Ohio | |
| Summit research Group, LLC | Recruiting |
| Stow, Ohio, United States, 44224 | |
| Contact: Scott Rigby, MD | |
| United States, Pennsylvania | |
| Northeast Clinical Research Center, LLC | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Nelson Kopyt, DO | |
| United States, Texas | |
| P&I Clinical Research, LLC | Recruiting |
| Lufkin, Texas, United States, 75904 | |
| Contact: Vickie Jones, LVN/CRN 936-465-9533 vjones@piclinicalresearch.com | |
| Briggs Clinical Research, LLC | Recruiting |
| San Antonio, Texas, United States, 78224 | |
| Contact: Raul Gaona, Sr., MD | |
Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
| Study Director: | C Tosone, MS, RAC | Allena Pharmaceuticals |
| Responsible Party: | Allena Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04987294 |
| Other Study ID Numbers: |
ALLN-346-202 |
| First Posted: | August 3, 2021 Key Record Dates |
| Last Update Posted: | December 6, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Gout Kidney Diseases Renal Insufficiency, Chronic Hyperuricemia Urologic Diseases Renal Insufficiency Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies |
Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Pathologic Processes Rasburicase Gout Suppressants Antirheumatic Agents |