CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Test Mealother
Likely dose
Not stated in record
Key inclusion· 4
  • ✓History of secondary hyperoxaluria (from enteric disease like Crohn's disease or bariatric surgery, or idiopathic) with kidney stones
  • ✓Urinary oxalate ≥40 mg/24 hr at screening
  • ✓Males or non-pregnant and non-lactating females
  • ✓No changes to stone-prevention medications (pyridoxine, thiazides, citrate, allopurinol) for ≥1 month prior and none anticipated during study
Key exclusion· 7
  • ✕Primary hyperoxaluria (only secondary hyperoxaluria eligible)
  • ✕eGFR <40 mL/min/1.73m² or acute renal failure
  • ✕Under- or over-collection on 24-hour urine (creatinine/kg outside gender-specific range)
  • ✕Allergy, intolerance, or inability to consume study foods or adhere to meal schedule

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095885
NCT03095885N/ACompleted
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A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Allena Pharmaceuticals·interventional·Posted Mar 30, 2017·Updated Oct 28, 2021

In Brief

A clinical study evaluating Test Meal for Secondary Hyperoxaluria and 3 related conditions. Completed, enrolled 22 participants across 5 sites.

Detailed Summary

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 30, 2017
Enrollment StartNov 1, 2016
Primary CompletionJan 1, 2017
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.3 years ago

Interventions

Test Mealother