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

Use our guide to learn which trials are right for you!

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
4085 University Boulevard South
Jacksonville, Florida 32216
1060
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Birmingham, Alabama
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
2 Rue Dubernat
Bordeaux, 33400
4756
mi
from
Bordeaux,
Click here to add this to my saved trials
Houston, Texas 77030
569
mi
from
Houston, TX
Click here to add this to my saved trials
New York, New York 10032
1290
mi
from
New York, NY
Click here to add this to my saved trials
Rochester, Minnesota
514
mi
from
Rochester, MN
Click here to add this to my saved trials
San Diego, California
1142
mi
from
San Diego, CA
Click here to add this to my saved trials