Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

Allena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperoxaluria; Nephrolithiasis

Treatments: Drug: ALLN-177

Study type: Interventional

Funder types: Industry

Identifiers

NCT02289755

0000396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ALLN-177

Experimental group

Description:

Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days.

Treatment:

Drug: ALLN-177