Phase 2
N=16
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Hyperoxaluria · Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT02289755 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion — -13.92 mg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALLN-177 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allena Pharmaceuticals
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion |
-13.92 | — |
| SECONDARY Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion |
-13.28 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02289755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.