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Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

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ClinicalTrials.gov Identifier: NCT02547805
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

Brief Summary:
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

Condition or disease Intervention/treatment Phase
Secondary Hyperoxaluria Nephrolithiasis Hyperoxaluria Kidney Stones Dietary Hyperoxaluria Drug: ALLN-177 Drug: Placebo Phase 2

Detailed Description:

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Placebo Comparator: Placebo
Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
Drug: Placebo
Placebo 5 capsules PO TID with meals

Experimental: ALLN-177
Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals
Drug: ALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
Other Name: Oxalate decarboxylase




Primary Outcome Measures :
  1. Mean change in urinary oxalate excretion (mg/24h) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Percent change in urinary oxalate excretion [ Time Frame: 28 days ]
  2. ≥ 7.5 mg/24 hr decrease in urinary oxalate [ Time Frame: 28 days ]
  3. ≥ 10 mg/24 hr decrease in urinary oxalate [ Time Frame: 28 days ]
  4. Mean change in urinary supersaturation of calcium oxalate [ Time Frame: 28 days ]
  5. Time-weighted average urinary oxalate excretion (mg/24h) [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of enteric or idiopathic hyperoxaluria or kidney stones
  • Urinary oxalate ≥ 50 mg/24 hours

Exclusion Criteria:

  • Hyperuricosuria
  • Glomerular filtration rate < 45 mL/min/1.73m2
  • Hypercalcemia or hyperthyroidism
  • Autoimmune disorder requiring systemic steroids
  • Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

Information from the National Library of Medicine

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): NCT02547805


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Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
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Study Director: Annamaria Kausz, MD MS VP Clinical Development

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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02547805     History of Changes
Other Study ID Numbers: 0000713
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Allena Pharmaceuticals:
Urine Oxalate
Nephrolithiasis
Kidney Stones
Hyperoxaluria
Enteric Hyperoxaluria
Idiopathic Hyperoxaluria
Urological Diseases
Kidney Diseases
Supersaturation
Dietary Oxalate
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Calculi
Nephrolithiasis
Hyperoxaluria
Calculi
Neoplastic Processes
Neoplasms
Pathologic Processes
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi