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Practitioner -uriROX-1Overview
 

uriROX-1 Overview


Allena is committed to providing safe and effective treatments for patients with rare and severe metabolic and kidney disorders, including enteric hyperoxaluria.


Protocol Title


Evaluate the Safety and Efficacy of ALLN-177 in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study (uriROX-1)

Protocol Number


ALLN-177-301

Phase of Development


Phase III

Study Treatment

ALLN-177 is a crystalline formulation of B. subtilis oxalate decarboxylase, an oxalate-degrading enzyme expressed in E. coli, which degrades oxalate to formate and carbon dioxide. Once the capsule is ingested (orally) with food, ALLN-177 degrades dietary oxalate, resulting in decreased oxalate available for absorption into the systemic circulation and subsequently reduced urinary oxalate (UOx) excretion.

Key Objectives


  • Determine the efficacy of ALLN-177 in reducing UOx excretion in subjects with enteric hyperoxaluria (HOx)
  • Evaluate the safety of ALLN-177 in subjects with enteric HOx

  • Key Eligibility Criteria


    Inclusion Criteria
    If your patient’s status is "yes" to the following questions, it is a good indicator that he or she may be eligible for the study. If you determine that the patient may be eligible, contact a study site.   


    • Is the patient 18 years of age or older?


    • Does the patient have a history of enteric hyperoxaluria (HOx) as defined below?

      • Documented urinary oxalate (UOx) excretion ≥50 mg/24-hour urine collection obtained within 6 months prior to Screening*
      AND documented malabsorptive disorder such as bariatric surgery, Crohn’s disease, short bowel syndrome, or other malabsorption syndrome

      • Note: Patients with known or suspected enteric HOx (e.g., history of kidney stones or oxalate nephropathy associated with an enteric disorder) who have not had a 24-hour urine collection in the past 6 months may perform a pre-screening 24-hour urine collection to determine eligibility.
    For patients taking concomitant medication for management of kidney stone risk factors: Has the patient been on a stable dose regimen for ≥8 weeks prior to and during Screening, with no changes in dosing anticipated during the remainder of the study?
     

    Exclusion Criteria
    If your patient’s status is "yes" to the following questions, it is a good indicator that he or she may NOT be eligible for the study.


    • Does the patient have HOx with a known cause other than an underlying enteric disorder associated with malabsorption (e.g., primary HOx, idopathic HOx)?


    • Is the patient unable or unwilling to discontinue Vitamin C supplementation at Screening and for the duration of the study?

    • Has the patient had any malignancy or treatment for malignancy within 12 months prior to Screening with the exception of localized basal cell or squamous cell skin cancer or any cancer in situ?

      • Note: Patients in remission and on a stable dose of chronic suppressive or maintenance therapy are NOT excluded. 
    • Does the patient have an active autoimmune disorder or other condition requiring therapy with high doses of systemic steroids (i.e., >10 mg/day prednisone or equivalent) or intensification of other immunosuppressant therapy within 4 weeks prior to Screening?
      • Note: Stable patients on low chronic or maintenance doses of steroids or other immunosuppressant drugs, including transplant recipients, are NOT excluded. 
     
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