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Shreveport, Louisiana 71106

  • Dietary Hyperoxaluria

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

0000713


NCT ID:

NCT02547805


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allena Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Actual


Overall Contact Information

Official Name:Annamaria Kausz, MD MS
Study Director
VP Clinical Development

Study Dates

Start Date:September 2015
Completion Date:January 2017
Completion Type:Actual
Primary Completion Date:January 2017
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 17, 2017
First Received Date:September 10, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mean change in urinary oxalate excretion (mg/24h)
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percent change in urinary oxalate excretion
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:≥ 7.5 mg/24 hr decrease in urinary oxalate
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:≥ 10 mg/24 hr decrease in urinary oxalate
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean change in urinary supersaturation of calcium oxalate
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time-weighted average urinary oxalate excretion (mg/24h)
Time Frame:28 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ALLN-177
Description:ALLN-177 7,500 units (5 capsules) PO TID with meals
Arm Name:ALLN-177
Other Name:Oxalate decarboxylase
Intervention Type:Drug
Name:Placebo
Description:Placebo 5 capsules PO TID with meals
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
Study Arm Type:Experimental
Arm Name:ALLN-177
Description:Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allena Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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