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

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

Sponsors

Lead sponsor: Allena Pharmaceuticals

Source Allena Pharmaceuticals
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.

Overall Status Completed
Start Date September 2014
Completion Date February 2015
Primary Completion Date January 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion 7 days
Secondary Outcome
Measure Time Frame
Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion 7 days
Enrollment 16
Condition
Intervention

Intervention type: Drug

Intervention name: ALLN-177

Description: 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.

Arm group label: ALLN-177

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lee Brettman, MD, FACP Study Director Medical Director
Location
facility
Indiana University Physicians Urology | Indianapolis, Indiana, 46202, United States
North Shore Long Island Jewish Health System | Lake Success, New York, 11042, United States
Cleveland Clinic | Cleveland, Ohio, 44195, United States
Omega Clinical Research | Warwick, Rhode Island, 02886, United States
Location Countries

United States

Verification Date

February 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ALLN-177

Arm group type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov