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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02289755
Other study ID # 0000396
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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