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 |
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).
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
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