A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
Completed · Phase 3
Conditions studied: Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
In brief
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
Key facts
- Study ID
- NCT04152200
- Run by
- Alnylam Pharmaceuticals
- People needed
- 21
- Starts
- 2020-01-21
- Expected to finish
- 2025-06-23
- Last updated by the study team
- 2025-07-18
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has documented diagnosis of primary hyperoxaluria type 1 (PH1)
- Estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m\^2 for patients ≥12 months of age (<12 months of age, must have serum creatinine considered elevated for age)
- Meets plasma oxalate level requirements
- If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days
- If on dialysis, may be on hemodialysis therapy only and must have been on a stable regimen for at least 4 weeks
You may not qualify if…
- Hemodialysis/peritoneal dialysis combination therapy or peritoneal dialysis alone
- Diagnosis of conditions other than PH1 contributing to renal insufficiency
- History of liver transplant
- History of kidney transplant and currently receiving immunosuppressants
Where it is running
- Clinical Trial Site — Rochester, Minnesota, United States
- Clinical Trial Site — Houston, Texas, United States
- Clinical Trial Site — Garran, Australia
- Clinical Trial Site — Brussels, Belgium
- Clinical Trial Site — Bron, France
- Clinical Trial Site — Lyon, France
- Clinical Trial Site — Haifa, Israel
- Clinical Trial Site — Nahariya, Israel
- Clinical Trial Site — Rome, Italy
- Clinical Trial Site — Irbid, Jordan
- Clinical Trial Site — Beirut, Lebanon
- Clinical Trial Site — Amsterdam, Netherlands
- Clinical Trial Site — Yenimahalle, Turkey (Türkiye)
- Clinical Trial Site — Dubai, United Arab Emirates
Full record on ClinicalTrials.gov
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