A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
NCT ID: NCT04152200
Last Updated: 2025-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
21 participants
INTERVENTIONAL
2020-01-21
2025-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lumasiran
All patients will receive open-label lumasiran.
Lumasiran
Lumasiran will be administered by subcutaneous (SC) injection.
Interventions
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Lumasiran
Lumasiran will be administered by subcutaneous (SC) injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Diagnosis of conditions other than PH1 contributing to renal insufficiency
* History of liver transplant
* History of kidney transplant and currently receiving immunosuppressants
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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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
Countries
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References
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Michael M, Groothoff JW, Shasha-Lavsky H, Lieske JC, Frishberg Y, Simkova E, Sellier-Leclerc AL, Devresse A, Guebre-Egziabher F, Bakkaloglu SA, Mourani C, Saqan R, Singer R, Willey R, Habtemariam B, Gansner JM, Bhan I, McGregor T, Magen D. Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial. Am J Kidney Dis. 2023 Feb;81(2):145-155.e1. doi: 10.1053/j.ajkd.2022.05.012. Epub 2022 Jul 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001346-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503382-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
ALN-GO1-005
Identifier Type: -
Identifier Source: org_study_id
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