Recurrent Calcium Oxalate Kidney Stone DiseasePhase 2NCT05161936
A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
A Phase 2 study testing Lumasiran in people with Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels, run by Alnylam Pharmaceuticals at 31 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels
- What is being tested?
- Lumasiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 27 Jan 2022to 1 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events with a minimum of 1 stone event within 5 years prior to screening
- Meets the 24 hour urine oxalate excretion requirements
- The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate
Who cannot join
- Known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones
- Primary hyperoxaluria
- Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 at screening
- Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States17 sites
Clinical Trial Site
Acworth, Georgia, 30101
Clinical Trial Site
Albany, New York, 12208
Clinical Trial Site
Birmingham, Alabama, 35233
Clinical Trial Site
Boston, Massachusetts, 02114
Clinical Trial Site
Carmel, Indiana, 46032
Clinical Trial Site
Edina, Minnesota, 55435
Clinical Trial Site
El Paso, Texas, 79902
Clinical Trial Site
Garden City, New York, 11530
Clinical Trial Site
Greensboro, North Carolina, 27403
Clinical Trial Site
Hialeah, Florida, 33016
Clinical Trial Site
Houston, Texas, 77054
Clinical Trial Site
Las Vegas, Nevada, 89128
Clinical Trial Site
North Charleston, South Carolina, 29405
Clinical Trial Site
Northridge, California, 91324
Clinical Trial Site
Quincy, Illinois, 62301
Clinical Trial Site
Rochester, Minnesota, 55905
Clinical Trial Site
San Francisco, California, 94143
Belgium4 sites
Clinical Trial Site
Brussels
Clinical Trial Site
Ghent
Clinical Trial Site
Kortrijk
Clinical Trial Site
Liège
Italy4 sites
Clinical Trial Site
Bologna
Clinical Trial Site
Pavia
Clinical Trial Site
Rome
Clinical Trial Site
Verona
Switzerland3 sites
Clinical Trial Site
Bern
Clinical Trial Site
Lausanne
Clinical Trial Site
Zurich
United Kingdom2 sites
Clinical Trial Site
Doncaster
Clinical Trial Site
Leeds
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
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.
- Being tested
- Lumasiran, Placebo
- Keywords
- Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumasiranDrug
Also called OXLUMO, ALN-GO1
Lumasiran will be administered by SC injection.
PlaceboDrug
Placebo will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Lumasiran Dose 1 | Experimental | Participants will be administered lumasiran by subcutaneous (SC) injection. Receives: Drug: Lumasiran |
| Lumasiran Dose 2 | Experimental | Participants will be administered lumasiran by SC injection. Receives: Drug: Lumasiran |
| Placebo | Placebo comparator | Participants will be administered placebo by SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
Measured: Baseline to Month 6
Secondary outcomes (2)
Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6
Measured: Baseline to Month 6
Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start27 Jan 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: Study terminated early due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Calcium Oxalate Kidney Stone DiseaseStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161936
- Sponsor's protocol ID
- ALN-GO1-008
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2021
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
- ClinicalTrials.gov ID
- NCT05161936
- Acronym / sponsor ID
- ALN-GO1-008
- Keywords
- Calcium oxalate, Kidney stones, Elevated urinary oxalate, Urinary oxalate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumasiran Dose 1 | Experimental | Drug: LumasiranParticipants will be administered lumasiran by subcutaneous (SC) injection. |
| Lumasiran Dose 2 | Experimental | Drug: LumasiranParticipants will be administered lumasiran by SC injection. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered placebo by SC injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events with a minimum of 1 stone event within 5 years prior to screening
- Meets the 24 hour urine oxalate excretion requirements
- The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate
Key exclusion criteria (4 listed)
- Known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones
- Primary hyperoxaluria
- Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 at screening
- Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumasiranAlso: OXLUMO, ALN-GO1Lumasiran will be administered by SC injection. | Drug | Lumasiran Dose 1, Lumasiran Dose 2 |
| PlaceboPlacebo will be administered by SC injection. | Drug | Placebo |
Primary outcome
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
Time frame: Baseline to Month 6
2 secondary outcomes
Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6
Time frame: Baseline to Month 6
Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6
Time frame: Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Alnylam Pharmaceuticals
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumasiran in people with Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels, run by Alnylam Pharmaceuticals at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Belgium, Italy, Switzerland, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6 (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.