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

Nephrolithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289755
• Other study ID #: 0000396
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxaluria
• Kidney Calculi
• Nephrolithiasis

Intervention

Drug:
• ALLN-177
ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Indiana University Physicians Urology	Indianapolis	Indiana
United States	North Shore Long Island Jewish Health System	Lake Success	New York
United States	Omega Clinical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion	Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).	7 days
Secondary	Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion	Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%	7 days