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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

1. Signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF) before undergoing any Screening procedure
2. Is = 18 years of age at Screening
3. Has a history of HOx (confirmed by documented UOx excretion = 50 mg/24 hr in the most recent 24-hour urine collection obtained within 6 months prior to Screening) that is secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn’s disease, short bowel syndrome, or other malabsorption syndrome)
- Note: Subjects with known or suspected HOx (e.g., history of kidney stones or oxalate nephropathy) without a 24-hour urine collection to determine UOx excretion within = 6 months of Screening may perform a pre-screening 24-hour urine collection after providing appropriate consent. This 24-hour urine collection can also be used to satisfy Inclusion Criterion No. 4, if obtained within 6 weeks prior to Screening
4. Has adequate (i.e., appropriate ratio of creatinine [mg]/body weight [kg] for gender) 24-hour urine collection at Screening, with resulting UOx excretion = 50 mg/24 hr
5. Has provided 2 adequate 24-hour urine collections at Baseline, with average urinary oxalate = 50 mg/24 hr (and neither is < 40 mg/24 hr).
6. For subjects taking concomitant medication for management of kidney stone risk factors (e.g., pyridoxine, thiazides, citrate supplements, allopurinol): has been on a stable dose regimen for >8 weeks prior to and during Screening, with no changes in dosing (dose level or dosing frequency) anticipated during the remainder of the study.
7. For female subjects: Is either medically incapable of pregnancy (e.g., has undergone hysterectomy or tubal ligation or has experienced prolonged [= 1year prior to Screening] amenorrhea) or, if a woman of childbearing potential, has a negative Screening serum pregnancy test, is not pregnant or nursing at Screening, and agrees to use an effective (approved by the Investigator) method of birth control for the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. Has > 30% variability in the ratio of creatinine (mg)/body weight (kg) among the three 24-hour urine samples collected prior to randomization (1 at Screening, 2 at Baseline)
2. Is in acute renal failure or has an estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2 at Screening
3. Has HOx with a known cause other than underlying enteric disorder associated with malabsorption (e.g., primary HOx)
4. Is unable or unwilling to discontinue Vitamin C supplementation at Screening and for the duration of the study
5. Any clinically significant findings during Screening, any ongoing clinically significant illness requiring changes in management within 4 weeks prior to or during Screening (e.g., flare of inflammatory bowel disease), or any planned surgical/invasive procedure during the study
6. 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: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded
7. Has 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 or during Screening
? Note: Stable subjects on low chronic or maintenance doses of steroids or other immunosuppressant drugs, including transplant recipients, are not excluded
8. Has received study drug (ALLN-177 or placebo) in any other ALLN-177 clinical study, or participation in another drug or device clinical trial within 30 days prior to or during Screening
9. Is not, per Investigator judgment, an ideal clinical trial candidate due to a personal issue (e.g., unwillingness/inability to comply with protocol) or medical condition (e.g., mental illness, laboratory abnormalities) that is likely to impede successful study completion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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