Not provided
Not provided
Not provided
Not provided
Not provided
Study terminated early due to low enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the effect of lumasiran on the percent change in urinary oxalate excretion in patients with recurrent calcium oxalate kidney stone disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumasiran Dose 1 | Experimental | Participants will be administered lumasiran by subcutaneous (SC) injection. |
|
| Lumasiran Dose 2 | Experimental | Participants will be administered lumasiran by SC injection. |
|
| Placebo | Placebo Comparator | Participants will be administered placebo by SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumasiran | Drug | Lumasiran will be administered by SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6 | Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6 | Baseline to Month 6 | |
| Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6 | Baseline to Month 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Birmingham | Alabama | 35233 | United States | ||
| Clinical Trial Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lumasiran Dose 1 | Participants will be administered lumasiran by subcutaneous (SC) injection. Lumasiran: Lumasiran will be administered by SC injection. |
| FG001 | Lumasiran Dose 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Feb 11, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo will be administered by SC injection. |
|
| Northridge |
| California |
| 91324 |
| United States |
| Clinical Trial Site | San Francisco | California | 94143 | United States |
| Clinical Trial Site | Hialeah | Florida | 33016 | United States |
| Clinical Trial Site | Acworth | Georgia | 30101 | United States |
| Clinical Trial Site | Quincy | Illinois | 62301 | United States |
| Clinical Trial Site | Carmel | Indiana | 46032 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | Edina | Minnesota | 55435 | United States |
| Clinical Trial Site | Rochester | Minnesota | 55905 | United States |
| Clinical Trial Site | Las Vegas | Nevada | 89128 | United States |
| Clinical Trial Site | Albany | New York | 12208 | United States |
| Clinical Trial Site | Garden City | New York | 11530 | United States |
| Clinical Trial Site | Greensboro | North Carolina | 27403 | United States |
| Clinical Trial Site | North Charleston | South Carolina | 29405 | United States |
| Clinical Trial Site | El Paso | Texas | 79902 | United States |
| Clinical Trial Site | Houston | Texas | 77054 | United States |
| Clinical Trial Site | Brussels | Belgium |
| Clinical Trial Site | Ghent | Belgium |
| Clinical Trial Site | Kortrijk | Belgium |
| Clinical Trial Site | Liège | Belgium |
| Clinical Trial Site | Bologna | Italy |
| Clinical Trial Site | Pavia | Italy |
| Clinical Trial Site | Rome | Italy |
| Clinical Trial Site | Verona | Italy |
| Clinical Trial Site | Madrid | Spain |
| Clinical Trial Site | Bern | Switzerland |
| Clinical Trial Site | Lausanne | Switzerland |
| Clinical Trial Site | Zurich | Switzerland |
| Clinical Trial Site | Doncaster | United Kingdom |
| Clinical Trial Site | Leeds | United Kingdom |
Participants will be administered lumasiran by SC injection.
Lumasiran: Lumasiran will be administered by SC injection.
| FG002 | Placebo | Participants will be administered placebo by SC injection. Placebo: Placebo will be administered by SC injection. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
No participants were enrolled or treated with Lumasiran Dose 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lumasiran Dose 1 | Participants will be administered lumasiran by subcutaneous (SC) injection. Lumasiran: Lumasiran will be administered by SC injection. |
| BG001 | Lumasiran Dose 2 | Participants will be administered lumasiran by SC injection. Lumasiran: Lumasiran will be administered by SC injection. |
| BG002 | Placebo | Participants will be administered placebo by SC injection. Placebo: Placebo will be administered by SC injection. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6 | No participant data was collected for this outcome measure due to early study termination. | Posted | Baseline to Month 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6 | No participant data was collected for this outcome measure due to early study termination. | Posted | Baseline to Month 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6 | No participant data was collected for this outcome measure due to early study termination. | Posted | Baseline to Month 6 |
|
|
Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumasiran Dose 1 | Participants will be administered lumasiran by subcutaneous (SC) injection. Lumasiran: Lumasiran will be administered by SC injection. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Lumasiran Dose 2 | Participants will be administered lumasiran by SC injection. Lumasiran: Lumasiran will be administered by SC injection. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Placebo | Participants will be administered placebo by SC injection. Placebo: Placebo will be administered by SC injection. | 0 | 1 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Alnylam Pharmaceuticals Inc. | 866-330-0326 | Clinicaltrials@alnylam.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2022 | Feb 11, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000716350 | lumasiran |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Italy |
|
| United Kingdom |
|
| Switzerland |
|
| Spain |
|