A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1



Status:Recruiting
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:6 - Any
Updated:3/14/2019
Start Date:September 26, 2018
End Date:May 2024
Contact:Alnylam Clinical Trials Information Line
Email:clinicaltrials@alnylam.com
Phone:1-877-ALNYLAM

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ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study With an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the efficacy and safety of Lumasiran in Children and
Adults with Primary Hyperoxaluria Type 1 (PH1).


Inclusion Criteria:

- Willing to provide written informed consent or assent and to comply with study
requirements

- Confirmation of PH1 disease

- Meet the 24 hour urine oxalate excretion requirements

- If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
days

Exclusion Criteria:

- Clinically significant health concerns (with the exception of PH1) or clinical
evidence of extrarenal systemic oxalosis

- Clinically significant abnormal laboratory results

- Known active or evidence of HIV or hepatitis B or C infection

- An estimated GFR of <= 45 mL/min/1.73m2 at screening

- Received an investigational agent within 30 days or 5 half-lives before the first dose
of study drug or are in follow-up of another clinical study

- History of kidney or liver transplant

- Known history of multiple drug allergies or allergic reaction to an oligonucleotide or
GalNAc

- History of intolerance to subcutaneous injection

- Women who are pregnant, planning a pregnancy, or breast-feeding or those of child
bearing potential and not willing to use contraception

- History of alcohol abuse within the last 12 months, or unable or unwilling to limit
alcohol consumption throughout the study
We found this trial at
7
sites
New York, New York 10032
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New York, NY
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Birmingham, Alabama
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Birmingham, AL
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2 Rue Dubernat
Bordeaux, 33400
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Bordeaux,
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Houston, Texas 77030
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Houston, TX
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4085 University Boulevard South
Jacksonville, Florida 32216
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Jacksonville, FL
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Rochester, Minnesota
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Rochester, MN
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San Diego, California
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San Diego, CA
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