Note: This study is currently only recruiting patients in the hospital.
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Suffer from Hyperoxaluria? GI Disorder and Kidney Stones?
This study is not recruiting.
Overview
What we are studying
We are looking for adults who have enteric hyperoxaluria that is caused by an underlying gastrointestinal condition. Enteric hyperoxaluria is caused by an underlying gastrointestinal condition that leads to absorption of When there is too much oxalate in the urine, it can bind with other ions to form crystals. These crystals Patients in this study will be screened using blood and urine samples to see if they are eligible to take the investigational drug. Patients found to be eligible will be offered the drug ALLN-177 or placebo (contains no active drug ingredients) over a 28 day period. Blood will be collected at 4 different time points and 24 hour urine samples will be
Hyperoxaluria is a condition in which there are high levels of oxalate in the urine. Oxalate is a chemical
substance found naturally in foods like spinach, nuts, chocolate, and tea. It is also a normal byproduct of
metabolism and is removed from the body by the kidneys as waste in the urine.
too much oxalate from foods.
Examples of such conditions include:
- Crohn’s disease and other inflammatory bowel diseases
- disorders of the pancreas due to cystic fibrosis or pancreatitis
- after gastric bypass surgery or surgery to remove a section of the intestine such as a Roux-en-Y procedure
may cause inflammation or grow into kidney stones. Those with hyperoxaluria are at an increased risk
for kidney stones or other kidney damage.
collected up to 11 different time points during the 12 week study.
Why it is important
We are doing this research study to learn more about the effects of the investigation drug (ALLN-177) on reducing the levels of oxalate in the urine compared to placebo (no active ingredients) in people with enteric hyperoxaluria.
What we hope to accomplish
We hope to find out if ALLN-177 is safe to take without causing too many side effects.
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Principal Investigator
Who can participate
To be eligible, you must be at least*: *Other criteria will apply. You will be required to complete a 24-hour urine collection during the Screening period to make sure you are eligible for the study.
What participants may be asked to do
Study participants will have an initial Screening Visit to assess their eligibility. Screening procedures will
include medical history, physical exam, vital signs, lab work, diet history and 24-hour urine
collections. Subjects who are found to be eligible for study participation after the screening period will be
randomized to either ALLN-177 or placebo. During the study, subjects will make 8 visits to the research
center and perform up to eleven 24-hour urine collections.
Project activities may include:
- Personal health tracking
- Blood draw
- Medication
- Office visit
Estimated time commitment
8 visits over 12 weeks
What participants may get
Participants will receive study-related procedures and study drug at no cost.
Location
Kidney Research Center
165 Cambridge St, Suite 302, Boston, MA 02114
Travel
- Accessible by public transportation
- Parking available
Travel and Parking Details
Accessible by public transportation
Parking available
Additional information
Study phase
Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.
Funding source
- Industry