Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03456830 |
Recruitment Status :
Completed
First Posted : March 7, 2018
Last Update Posted : February 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Enteric Hyperoxaluria | Drug: ALLN-177 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 115 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study |
Actual Study Start Date : | May 21, 2018 |
Actual Primary Completion Date : | September 30, 2019 |
Actual Study Completion Date : | October 28, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: ALLN-177
ALLN-177 3,750 units per capsule
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Drug: ALLN-177
ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
Other Name: Oxalate decarboxylase |
Placebo Comparator: Placebo
Placebo capsule
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Drug: Placebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days |
- Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 [ Time Frame: 4 weeks ]Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
- Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4 [ Time Frame: 4 weeks ]Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provided informed consent
- Age 18 or older
- History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- Urinary Oxalate ≥ 50mg/24h
Exclusion Criteria:
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456830

Study Director: | Annamaria Kausz, MD MS | Allena Pharmaceuticals Inc |
Responsible Party: | Allena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03456830 |
Other Study ID Numbers: |
ALLN-177-301 |
First Posted: | March 7, 2018 Key Record Dates |
Last Update Posted: | February 27, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney stones Hyperoxaluria Enteric hyperoxaluria Oxalate |