A Phase 3 interventional study of Reloxaliase and Placebo in Enteric Hyperoxaluria, sponsored by Allena Pharmaceuticals. Terminated at 113 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Allena Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 92 is close to the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi 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.
Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
Drug: Reloxaliase
placebo capsule
Drug: Placebo
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Also known as: ALLN-177, Oxalate decarboxylase
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Also known as: Placebo capsule
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4
Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
Time frame: 4 weeks
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo
Time frame: up to 48 months
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24
Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment
Time frame: 24 weeks
Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Time frame: 4 weeks
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones
Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo
Time frame: up to 48 months
Change in estimated glomerular filtration rate (eGFR) from baseline
Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo
Time frame: up to 48 months
Showing the first 100 of 113 sites across 16 countries. Choose a country and city above to see the rest.
Plan to share: No
This study is terminated, as verified in Jun 2022. 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