A Phase 2 interventional study of ALLN-177 in Enteric Hyperoxaluria, Primary Hyperoxaluria and Hyperoxalemia, sponsored by Allena Pharmaceuticals. Completed at 9 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-12-30.
Sponsored by Allena Pharmaceuticals · Phase 2, Interventional, and Treatment
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .
Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's enrollment of 15 is below the median of 24 across 26 interventional studies indexed under Hyperoxaluria, Primary.
Browse Hyperoxaluria, Primary studies →Allena Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALLN-177 7,500 units (2 capsules)
Drug: ALLN-177
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Also known as: Oxalate decarboxylase
Change in plasma oxalate
Efficacy will be assessed based on change from baseline in plasma oxalate
Time frame: on 12 weeks of treatment
Change in 24-hr urinary oxalate excretion
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Time frame: on 12 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Dec 2019, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reloxaliase
Allena Pharmaceuticals