Trial Outcomes & Findings for A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels (NCT NCT05161936)
NCT ID: NCT05161936
Last Updated: 2024-05-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
Lumasiran Dose 1
Participants will be administered lumasiran by subcutaneous (SC) injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Placebo
Participants will be administered placebo by SC injection.
Placebo: Placebo will be administered by SC injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lumasiran Dose 1
Participants will be administered lumasiran by subcutaneous (SC) injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Placebo
Participants will be administered placebo by SC injection.
Placebo: Placebo will be administered by SC injection.
|
|---|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Baseline characteristics by cohort
| Measure |
Lumasiran Dose 1
n=1 Participants
Participants will be administered lumasiran by subcutaneous (SC) injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Placebo
n=1 Participants
Participants will be administered placebo by SC injection.
Placebo: Placebo will be administered by SC injection.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
52 years
n=99 Participants
|
—
|
65 years
n=206 Participants
|
58.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: No participant data was collected for this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 6Population: No participant data was collected for this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 6Population: No participant data was collected for this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
Adverse Events
Lumasiran Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lumasiran Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lumasiran Dose 1
n=1 participants at risk
Participants will be administered lumasiran by subcutaneous (SC) injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Lumasiran Dose 2
Participants will be administered lumasiran by SC injection.
Lumasiran: Lumasiran will be administered by SC injection.
|
Placebo
n=1 participants at risk
Participants will be administered placebo by SC injection.
Placebo: Placebo will be administered by SC injection.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
100.0%
1/1 • Number of events 1 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
—
0/0 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
0.00%
0/1 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
—
0/0 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
100.0%
1/1 • Number of events 1 • Up to 9 months
No participants were enrolled or treated with Lumasiran Dose 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place