Clinical trial NCT02289755: Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Official title: A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperoxaluria
Nephrolithiasis
Keywords: Urine Oxalate
Nephrolithiasis
Kidney Stones
Hyperoxaluria
Enteric Hyperoxaluria
Idiopathic Hyperoxaluria
Urological Diseases
Kidney Diseases
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

Detailed description: A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Able to comply with study procedures
* History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone
* Hyperoxaluria \>36mg of oxalate/24-hr
* May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

* Uric acid ≥1.5g/24-hr
* Estimated glomerular filtration rate of \< 60 mL/min
* Positive results from drug urine screen
* Requires daily vitamin C (defined as \>10 days of \>300 mg/day)
* Diagnosis of hypercalcemia or hypothyroidism
* Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney.
* Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.
* Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial
* History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.
* Taken investigational compound within 30 days prior to the first day of the study
* Treatment with cholestyramine
* Average daily dietary intake of \<75 mg oxalate per day calculated from diet recalls

Primary outcomes:
measure: Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion
timeFrame: 7 days
Secondary outcomes:
measure: Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion
timeFrame: 7 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Physicians Urology
state: Indiana
city: Lake Success
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Warwick
country: United States
facility: Omega Clinical Research
state: Rhode Island
Study officials:
affiliation: Medical Director
name: Lee Brettman, MD, FACP
role: STUDY_DIRECTOR
References:
citation: Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.