Allena is committed to providing safe and effective treatments for patients with rare and severe metabolic and kidney disorders, including enteric hyperoxaluria.
Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (uriROX-2)
Phase of Development
Reloxaliase (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 taken (orally) with food, reloxaliase degrades dietary oxalate, resulting in decreased oxalate available for absorption into systemic circulation and subsequently reduced urinary oxalate (UOx) excretion.
The safety and effectiveness of reloxaliase are being tested against placebo, a capsule that looks the same as reloxaliase but does not have active ingredients.
- Determine the efficacy effect of reloxaliase in reducing UOx excretion in subjects with enteric HOx
- Evaluate the long-term safety of reloxaliase
- Evaluate the long-term effect of treatment with reloxaliase on kidney stone disease progression and kidney function
- Assess impact of treatment with reloxaliase on burden of illness (kidney stone associate healthcare resource utilization
Key Eligibility 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 an underlying enteric disorder associated with malabsorption? Examples could include malabsorptive bariatric
surgery (e.g., Roux-en-Y gastric bypass, jejunoileal bypass, biliopancreatic
diversion) a minimum of 12 months prior to screening, short bowel syndrome,
inflammatory bowel disease with small bowel involvement, cystic fibrosis,
pancreatic insufficiency, or celiac disease.
- Note: Patients who have had restrictive-only bariatric procedures (e.g., vertical banded gastroplasty, adjustable gastric banding, sleeve gastrectomy) are not eligible.
- Patients with a current ileostomy or a total colectomy are not eligible.
- Does the patient have a known or suspected history of HOx (e.g., history of kidney stones or oxalate nephropathy)?
- Does the patient have at least 1 documented kidney stone (spontaneous kidney stone passage or intervention to remove kidney stone, or new or enlarged stone on imaging) within 2 years prior to screening?
- For patients taking concomitant medication for management of kidney stone risk factors (e.g., thiazides, calcium supplements, alkali therapy, allopurinol): has the patient been on a stable dose regimen for ≥8 weeks prior to screening, and with no changes in dosing (dose level or dosing frequency) anticipated during the first 24 weeks of the study treatment period?
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 a known genetic,
congenital, or other cause of kidney stones (e.g., primary hyperoxaluria,
primary hyperparathyroidism, medullary sponge kidney), OR recent kidney stone
was determined to be due to an infection (e.g., struvite stone, recurrent
urinary tract infections),medications associated with crystalluria (e.g.,
carbonic anhydrase inhibitors [acetazolamide, topiramate], triamterene,
protease inhibitors, guaifenesin, ephedrine, sulfonamides), or medications
known to cause fat malabsorption (e.g., orlistat)?
- 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 dose regimens of steroids or other immunosuppressant drugs, including transplant recipients, are NOT excluded.