Back to resultsA Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (ILLUMINATE-C)
Primary Purpose
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumasiran
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hyperoxaluria Type 1 focused on measuring PH1, Primary Hyperoxaluria, Hyperoxaluria, RNAi Therapeutic, siRNA, AGT, Systemic Oxalosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Clinical Trial Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lumasiran
Arm Description
All patients will receive open-label lumasiran.
Outcomes
Primary Outcome Measures
Cohort A: Percent Change in Plasma Oxalate From Baseline to Month 6
Percent change in plasma oxalate (umol/L) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort A, the baseline was defined as the mean of all plasma oxalate level values collected prior to the first dose of lumasiran.
Cohort B: Percent Change in Pre-dialysis Plasma Oxalate From Baseline to Month 6
Percent change in plasma oxalate (umol/L) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort B, the baseline is defined as the mean of the last four pre-dialysis plasma oxalate samples collected prior to the first dose of lumasiran. In Cohort B, only pre-dialysis samples are utilized.
Secondary Outcome Measures
Cohort B: Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 6
Percent change in plasma oxalate AUC(0-24) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean value of all valid AUC (μmol/L/24h) profiles being computed prior to the first dose of lumasiran.
Absolute Change in Plasma Oxalate From Baseline to Month 6
Absolute change in plasma oxalate was estimated by an average absolute change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort A, the baseline was defined as the mean of all plasma oxalate level values collected prior to the first dose of lumasiran; for Cohort B, the baseline was defined as the mean of the last 4 pre-dialysis plasma oxalate level values collected prior to the first dose of lumasiran. In Cohort B patients, the plasma oxalate baseline was similarly defined except that the values obtained from the plasma oxalate profile assessment visits only included the pre-dialysis sample collected per visit.
Cohort A: Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6
Absolute change in 24-hour urinary oxalate excretion corrected for BSA was estimated by an average absolute change from baseline across Months 3 through 6. Only valid urine samples without any non-protocol-related issues were included in the analysis. A negative change from Baseline indicates a favorable outcome. Baseline is defined as the median of all valid 24-hr urine assessments collected prior to the first dose date/time of lumasiran without any non-protocol-related sample issues.
Cohort A: Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6
Percent change in 24-hour urinary oxalate excretion corrected for BSA was estimated by an average percent change from baseline across Months 3 through 6. Only valid urine samples without any non-protocol-related issues were included in the analysis. A negative change from Baseline indicates a favorable outcome. Baseline is defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Cohort A: Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6
Absolute change in spot urinary oxalate:creatinine ratio was estimated by an average absolute change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Cohort A: Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6
Percent change in spot urinary oxalate:creatinine ratio was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 6 in Patients >=2 to 18 Years of Age at Time of Informed Consent
Peds-QL is a modular approach to measuring quality of life (QOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Generic Core Scales contain 23 items designed to measure core domains of health (physical, emotional, and social functioning) and role (school functioning). Scores are summarized as Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score. The Total Scale Score will be reported for this study. The PedsQL will be completed by patients (or caregivers, as appropriate) who are ≥2 to <18 years of age at the time of consent. Total score range: 0 - 100, with higher scores indicating better health-related quality of life (HRQoL). Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 6 in Patients ≥18 Years of Age at Time of Informed Consent
The KDQOL questionnaire is used to assess 3 core domains of kidney disease including: burden, symptoms/problems, and effects of kidney disease on daily life. The KDQOL subscales (Burden of Kidney Disease, Effect of Kidney Disease on Daily Life, and Symptoms and Problems of Kidney Disease), and the accompanying Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary will be assessed for this study. These will be completed by patients who are ≥18 years of age at the time of consent. Score range (per domain): 0 - 100; higher scores indicate better HRQoL. Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Maximum Plasma Concentration (Cmax) of Lumasiran
Cmax is the highest concentration of lumasiran in the plasma after a dose is given.
Time to Maximum Plasma Concentration (Tmax) of Lumasiran
Tmax is the time it takes for lumasiran to reach the maximum concentration (Cmax) after administration.
Elimination Half-life (t½β) of Lumasiran
t½β is the time it takes for the concentration of the drug in the plasma to be reduced by 50%.
Area Under the Concentration-time Curve From 0 to 24 Hours [AUC(0-24)] for Lumasiran
AUC(0-24) is the area under the plasma concentration-time curve over the last 24-h dosing interval.
Apparent Clearance (CL/F) of Lumasiran
CL/F is the rate at which lumasiran is eliminated from the body.
Apparent Volume of Distribution (V/F) of Lumasiran
V/F is the propensity of lumasiran to either remain in the plasma or redistribute to other tissues.
Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 60
Absolute Change in Plasma Oxalate From Baseline to Month 60
Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60
Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60
Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60
Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60
Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 60 in Patients >=2 to 18 Years of Age at Time of Informed Consent
Peds-QL is a modular approach to measuring quality of life (QOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Generic Core Scales contain 23 items designed to measure core domains of health (physical, emotional, and social functioning) and role (school functioning). Scores are summarized as Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score. The Total Scale Score will be reported for this study. The PedsQL will be completed by patients (or caregivers, as appropriate) who are ≥2 to <18 years of age at the time of consent. Total score range: 0 - 100, with higher scores indicating better health-related quality of life (HRQoL). Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 60 in Patients ≥18 Years of Age at Time of Informed Consent
The KDQOL questionnaire is used to assess 3 core domains of kidney disease including: burden, symptoms/problems, and effects of kidney disease on daily life. The KDQOL subscales (Burden of Kidney Disease, Effect of Kidney Disease on Daily Life, and Symptoms and Problems of Kidney Disease), and the accompanying Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary will be assessed for this study. These will be completed by patients who are ≥18 years of age at the time of consent. Score range (per domain): 0 - 100; higher scores indicate better HRQoL. Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Percent Change in Plasma Oxalate From Baseline to End of Study
Change in Nephrocalcinosis From Baseline to End of Study
Nephrocalcinosis will be assessed by renal ultrasound.
Change in Frequency of Dialysis From Baseline to End of Study
Change in Mode of Dialysis From Baseline to End of Study
Modes of dialysis are defined as hemodialysis and peritoneal dialysis.
Change in Frequency of Renal Stone Events From Baseline to End of Study
Change in Renal Function Assessed by Estimated Glomerular Filtration Rate (eGFR) From Baseline to End of Study
Change in Measures of Systemic Oxalosis From Baseline to End of Study
Systemic oxalosis will be assessed in cardiac, skeletal, ophthalmologic, and dermatologic systems.
Full Information
NCT ID
NCT04152200
First Posted
October 31, 2019
Last Updated
October 20, 2023
Sponsor
Alnylam Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04152200
Brief Title
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
Acronym
ILLUMINATE-C
Official Title
ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (PH1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alnylam Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
Keywords
PH1, Primary Hyperoxaluria, Hyperoxaluria, RNAi Therapeutic, siRNA, AGT, Systemic Oxalosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumasiran
Arm Type
Experimental
Arm Description
All patients will receive open-label lumasiran.
Intervention Type
Drug
Intervention Name(s)
Lumasiran
Other Intervention Name(s)
ALN-GO1, OXLUMO
Intervention Description
Lumasiran will be administered by subcutaneous (SC) injection.
Primary Outcome Measure Information:
Title
Cohort A: Percent Change in Plasma Oxalate From Baseline to Month 6
Description
Percent change in plasma oxalate (umol/L) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort A, the baseline was defined as the mean of all plasma oxalate level values collected prior to the first dose of lumasiran.
Time Frame
Baseline to Month 6
Title
Cohort B: Percent Change in Pre-dialysis Plasma Oxalate From Baseline to Month 6
Description
Percent change in plasma oxalate (umol/L) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort B, the baseline is defined as the mean of the last four pre-dialysis plasma oxalate samples collected prior to the first dose of lumasiran. In Cohort B, only pre-dialysis samples are utilized.
Time Frame
Baseline to Month 6
Secondary Outcome Measure Information:
Title
Cohort B: Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 6
Description
Percent change in plasma oxalate AUC(0-24) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean value of all valid AUC (μmol/L/24h) profiles being computed prior to the first dose of lumasiran.
Time Frame
Baseline to Month 6
Title
Absolute Change in Plasma Oxalate From Baseline to Month 6
Description
Absolute change in plasma oxalate was estimated by an average absolute change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort A, the baseline was defined as the mean of all plasma oxalate level values collected prior to the first dose of lumasiran; for Cohort B, the baseline was defined as the mean of the last 4 pre-dialysis plasma oxalate level values collected prior to the first dose of lumasiran. In Cohort B patients, the plasma oxalate baseline was similarly defined except that the values obtained from the plasma oxalate profile assessment visits only included the pre-dialysis sample collected per visit.
Time Frame
Baseline to Month 6
Title
Cohort A: Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6
Description
Absolute change in 24-hour urinary oxalate excretion corrected for BSA was estimated by an average absolute change from baseline across Months 3 through 6. Only valid urine samples without any non-protocol-related issues were included in the analysis. A negative change from Baseline indicates a favorable outcome. Baseline is defined as the median of all valid 24-hr urine assessments collected prior to the first dose date/time of lumasiran without any non-protocol-related sample issues.
Time Frame
Baseline to Month 6
Title
Cohort A: Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6
Description
Percent change in 24-hour urinary oxalate excretion corrected for BSA was estimated by an average percent change from baseline across Months 3 through 6. Only valid urine samples without any non-protocol-related issues were included in the analysis. A negative change from Baseline indicates a favorable outcome. Baseline is defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Time Frame
Baseline to Month 6
Title
Cohort A: Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6
Description
Absolute change in spot urinary oxalate:creatinine ratio was estimated by an average absolute change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Time Frame
Baseline to Month 6
Title
Cohort A: Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6
Description
Percent change in spot urinary oxalate:creatinine ratio was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. Baseline was defined as the mean of all assessments prior to the first dose date/time of lumasiran.
Time Frame
Baseline to Month 6
Title
Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 6 in Patients >=2 to 18 Years of Age at Time of Informed Consent
Description
Peds-QL is a modular approach to measuring quality of life (QOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Generic Core Scales contain 23 items designed to measure core domains of health (physical, emotional, and social functioning) and role (school functioning). Scores are summarized as Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score. The Total Scale Score will be reported for this study. The PedsQL will be completed by patients (or caregivers, as appropriate) who are ≥2 to <18 years of age at the time of consent. Total score range: 0 - 100, with higher scores indicating better health-related quality of life (HRQoL). Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Time Frame
Baseline to Month 6
Title
Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 6 in Patients ≥18 Years of Age at Time of Informed Consent
Description
The KDQOL questionnaire is used to assess 3 core domains of kidney disease including: burden, symptoms/problems, and effects of kidney disease on daily life. The KDQOL subscales (Burden of Kidney Disease, Effect of Kidney Disease on Daily Life, and Symptoms and Problems of Kidney Disease), and the accompanying Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary will be assessed for this study. These will be completed by patients who are ≥18 years of age at the time of consent. Score range (per domain): 0 - 100; higher scores indicate better HRQoL. Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Time Frame
Baseline to Month 6
Title
Maximum Plasma Concentration (Cmax) of Lumasiran
Description
Cmax is the highest concentration of lumasiran in the plasma after a dose is given.
Time Frame
Day 1; Month 6
Title
Time to Maximum Plasma Concentration (Tmax) of Lumasiran
Description
Tmax is the time it takes for lumasiran to reach the maximum concentration (Cmax) after administration.
Time Frame
Day 1; Month 6
Title
Elimination Half-life (t½β) of Lumasiran
Description
t½β is the time it takes for the concentration of the drug in the plasma to be reduced by 50%.
Time Frame
Day 1; Month 6
Title
Area Under the Concentration-time Curve From 0 to 24 Hours [AUC(0-24)] for Lumasiran
Description
AUC(0-24) is the area under the plasma concentration-time curve over the last 24-h dosing interval.
Time Frame
Day 1; Month 6
Title
Apparent Clearance (CL/F) of Lumasiran
Description
CL/F is the rate at which lumasiran is eliminated from the body.
Time Frame
Day 1; Month 6
Title
Apparent Volume of Distribution (V/F) of Lumasiran
Description
V/F is the propensity of lumasiran to either remain in the plasma or redistribute to other tissues.
Time Frame
Day 1; Month 6
Title
Percent Change in Plasma Oxalate Area Under the Curve From 0-24 Hours [AUC(0-24)] Between Dialysis Sessions From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Absolute Change in Plasma Oxalate From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Absolute Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Absolute Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Percent Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 60
Time Frame
Baseline to Month 60
Title
Change in Quality of Life As Assessed by Pediatric Quality of Life Inventory (PedsQL) Total Score From Baseline to Month 60 in Patients >=2 to 18 Years of Age at Time of Informed Consent
Description
Peds-QL is a modular approach to measuring quality of life (QOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Generic Core Scales contain 23 items designed to measure core domains of health (physical, emotional, and social functioning) and role (school functioning). Scores are summarized as Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score. The Total Scale Score will be reported for this study. The PedsQL will be completed by patients (or caregivers, as appropriate) who are ≥2 to <18 years of age at the time of consent. Total score range: 0 - 100, with higher scores indicating better health-related quality of life (HRQoL). Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Time Frame
Baseline to Month 60
Title
Change in Quality of Life As Assessed by Kidney Disease and Quality of Life (KDQOL) Scores From Baseline to Month 60 in Patients ≥18 Years of Age at Time of Informed Consent
Description
The KDQOL questionnaire is used to assess 3 core domains of kidney disease including: burden, symptoms/problems, and effects of kidney disease on daily life. The KDQOL subscales (Burden of Kidney Disease, Effect of Kidney Disease on Daily Life, and Symptoms and Problems of Kidney Disease), and the accompanying Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary will be assessed for this study. These will be completed by patients who are ≥18 years of age at the time of consent. Score range (per domain): 0 - 100; higher scores indicate better HRQoL. Baseline is defined as last non-missing value collected prior to the first dose of lumasiran.
Time Frame
Baseline to Month 60
Title
Percent Change in Plasma Oxalate From Baseline to End of Study
Time Frame
Baseline to Month 60
Title
Change in Nephrocalcinosis From Baseline to End of Study
Description
Nephrocalcinosis will be assessed by renal ultrasound.
Time Frame
Baseline to Month 60
Title
Change in Frequency of Dialysis From Baseline to End of Study
Time Frame
Baseline to Month 60
Title
Change in Mode of Dialysis From Baseline to End of Study
Description
Modes of dialysis are defined as hemodialysis and peritoneal dialysis.
Time Frame
Baseline to Month 60
Title
Change in Frequency of Renal Stone Events From Baseline to End of Study
Time Frame
Baseline to Month 60
Title
Change in Renal Function Assessed by Estimated Glomerular Filtration Rate (eGFR) From Baseline to End of Study
Time Frame
Baseline to Month 60
Title
Change in Measures of Systemic Oxalosis From Baseline to End of Study
Description
Systemic oxalosis will be assessed in cardiac, skeletal, ophthalmologic, and dermatologic systems.
Time Frame
Baseline to Month 60
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Alnylam Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Site
City
Garran
Country
Australia
Facility Name
Clinical Trial Site
City
Brussels
Country
Belgium
Facility Name
Clinical Trial Site
City
Bron
Country
France
Facility Name
Clinical Trial Site
City
Lyon
Country
France
Facility Name
Clinical Trial Site
City
Haifa
Country
Israel
Facility Name
Clinical Trial Site
City
Nahariya
Country
Israel
Facility Name
Clinical Trial Site
City
Rome
Country
Italy
Facility Name
Clinical Trial Site
City
Irbid
Country
Jordan
Facility Name
Clinical Trial Site
City
Beirut
Country
Lebanon
Facility Name
Clinical Trial Site
City
Amsterdam
Country
Netherlands
Facility Name
Clinical Trial Site
City
Yenimahalle
Country
Turkey
Facility Name
Clinical Trial Site
City
Dubai
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35843439
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
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