HaemodialysisPhase 2LHOxHNCT06225544
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
A Phase 2 study testing Lumasiran in people with Haemodialysis and Chronic Kidney Disease Requiring Chronic Dialysis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Disease
- 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
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2024to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Aged between 18 and 80 years old at the start of the study.
- Women of child-bearing potential to consent to either abstinence or the use of contraception during the study period
- Patients must have capacity to give written, informed consent to participate in the study prior to commencing the study. They must be fully aware of the aims, nature, planned interventions and potential risks of participating in the study. This consent must be obtained by the time of participant inclusion.
- Established and stable on haemodialysis for at least 2 months
- Thrice weekly haemodialysis
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- In possession of permanent dialysis access - either arterio-venous fistula (AVF) or graft (AVG) or permanent dialysis catheter/tunnelled haemodialysis line (THL).
- ESKD not caused by previously diagnosed primary hyperoxaluria.
- Mean baseline serum oxalate level of ≥20 μmol/L
- No recent (within last 2 months) significant changes to regular medications or diet
Who cannot join
- Known diagnosis of PH1, 2 or 3; or a pathological mutation documented to cause primary hyperoxaluria.
- Established on haemodialysis for less than 2 months.
- On peritoneal dialysis.
- Combined haemodialysis and peritoneal dialysis.
- Temporary or poorly functioning haemodialysis access
- Pregnancy, planning pregnancy or currently breast feeding.
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- Co-morbidity of an enteric disorder such as Inflammatory Bowel Disease (IBD), short gut syndrome, or a malabsorptive disorder.
- Decompensated Liver failure.
- Intercurrent active infection and/or antibiotic treatment.
- Currently on Vitamin C treatment with a daily dose of more than 250mg.
- Terminal illness and/or life expectancy of less than 1 year.
- Currently relapsed or uncontrolled and symptomatic psychiatric disorder preventing compliance with the study.
- Participants institutionalised by court or government order.
- Patients who could be coerced due to dependency on the sponsor, the investigator, the trial sites or test centres.
- Deranged liver function tests: If alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than twice the upper limit
Trial locations and contacts
1 site in 1 country.
Gerlineke MC Hawkins-van der Cingel, MBBS contact
Germany1 site, 1 recruiting
- Recruiting
Charite Universtiätsmedizin
Berlin
Gerlineke Hawkins-van der Cingel, MBBS
About this study
This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis.
The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study.
At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.
Read the detailed description
This is an investigator-initiated, double-blind, phase II two-centre medications study with an intervention and placebo arm.
The principal objective of this study is to establish if the administration of lumasiran versus placebo can effectively lower pre-dialysis oxalate levels in hyperoxalaemic haemodialysis patients with any cause of ESKD (end stage kidney disease) except known primary hyperoxaluria.
The hypothesis is that compared to placebo, the administration of lumasiran (the study drug) will reduce serum oxalate levels at 3-6 months post first dose in hyperoxalaemic haemodialysis patients.
This study will evaluate the use of lumasiran in haemodialysis patients. Lumasiran will be dosed as per the SmPC published by the European Medicines Agency. Monthly pre-dialysis plasma oxalate measurements will be taken to assess the effect of lumasiran on lowering the oxalate levels versus a placebo. Thus far studies have shown lumasiran to be well tolerated. The tolerability in this patient cohort will be evaluated and monitor inflammatory and cardiovascular biomarkers in addition to cardiac imaging with echocardiograms.
- Conditions
- Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Disease, Cardiovascular Risk Factor, Hyperoxalemia
- Being tested
- Lumasiran, 0.9% Sodium Chloride (placebo)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumasiranDrug
Subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.
0.9% Sodium Chloride (placebo)Drug
Placebo, subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.
| Study group | Role | What they receive |
|---|---|---|
| Lumasiran, treatment arm | Experimental | Treatment arm with Lumasiran Receives: Drug: Lumasiran |
| Placebo | Placebo comparator | Placebo injection with 0.9% sodium chloride Receives: Drug: 0.9% Sodium Chloride (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dialysis Plasma Oxalate concentration
The primary endpoint is the percentage change in pre-dialysis plasma oxalate levels in non-primary hyperoxaluria patients with raised plasma oxalate levels who are receiving maintenance haemodialysis.
Measured: It will be measured at baseline and month 1-6 (weeks 4, 8, 12, 16, 20 and 24).
Secondary outcomes (2)
Absolute change in pre-dialysis mean plasma
Absolute change in pre-dialysis mean plasma oxalate levels from baseline to month 3-6, comparing the treatment group with the placebo group.
Measured: Baseline to month 3-6,
Side effects (tolerability)
Tolerability will be assessed using an adapted FACIT Instrument validated questionnaire (severity of side effects rated on scale between 0 and 4). Again, the answers of the two study arms will be compared.
Measured: Monthly - month 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start14 Apr 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Model description
- This is a randomised controlled trial with parallel arms of placebo versus study drug (lumasiran). With a 1:1 ratio between the two groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Alnylam Pharmaceuticals
- Responsible party
- Principal investigator, Gerlineke Hawkins-van der Cingel, Charite University, Berlin, Germany
- Investigators
- Felix Knauf, MD, Principal investigator, Charite Universitätsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225544
- Sponsor's protocol ID
- 20018510
- Other IDs
- 2022-002681-32
- Acronym
- LHOxH
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumasiran in Hyperoxalaemic Patients on Haemodialysis
- ClinicalTrials.gov ID
- NCT06225544
- Acronym / sponsor ID
- LHOxH / 20018510
- Conditions
- Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Disease, Cardiovascular Risk Factor, Hyperoxalemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Alnylam Pharmaceuticals
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis.
The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study.
At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.
Detailed description
This is an investigator-initiated, double-blind, phase II two-centre medications study with an intervention and placebo arm.
The principal objective of this study is to establish if the administration of lumasiran versus placebo can effectively lower pre-dialysis oxalate levels in hyperoxalaemic haemodialysis patients with any cause of ESKD (end stage kidney disease) except known primary hyperoxaluria.
The hypothesis is that compared to placebo, the administration of lumasiran (the study drug) will reduce serum oxalate levels at 3-6 months post first dose in hyperoxalaemic haemodialysis patients.
This study will evaluate the use of lumasiran in haemodialysis patients. Lumasiran will be dosed as per the SmPC published by the European Medicines Agency. Monthly pre-dialysis plasma oxalate measurements will be taken to assess the effect of lumasiran on lowering the oxalate levels versus a placebo. Thus far studies have shown lumasiran to be well tolerated. The tolerability in this patient cohort will be evaluated and monitor inflammatory and cardiovascular biomarkers in addition to cardiac imaging with echocardiograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised controlled trial with parallel arms of placebo versus study drug (lumasiran). With a 1:1 ratio between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Lumasiran, treatment arm | Experimental | Drug: LumasiranTreatment arm with Lumasiran |
| Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride (placebo)Placebo injection with 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients
- Aged between 18 and 80 years old at the start of the study.
- Women of child-bearing potential to consent to either abstinence or the use of contraception during the study period
- Patients must have capacity to give written, informed consent to participate in the study prior to commencing the study. They must be fully aware of the aims, nature, planned interventions and potential risks of participating in the study. This consent must be obtained by the time of participant inclusion.
- Established and stable on haemodialysis for at least 2 months
Key exclusion criteria (15 listed)
- Known diagnosis of PH1, 2 or 3; or a pathological mutation documented to cause primary hyperoxaluria.
- Established on haemodialysis for less than 2 months.
- On peritoneal dialysis.
- Combined haemodialysis and peritoneal dialysis.
- Temporary or poorly functioning haemodialysis access
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 |
|---|---|---|
| LumasiranSubcutaneous injection, given as three monthly loading doses followed by one further maintenance dose. | Drug | Lumasiran, treatment arm |
| 0.9% Sodium Chloride (placebo)Placebo, subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose. | Drug | Placebo |
Primary outcome
Pre-dialysis Plasma Oxalate concentration
Time frame: It will be measured at baseline and month 1-6 (weeks 4, 8, 12, 16, 20 and 24).
The primary endpoint is the percentage change in pre-dialysis plasma oxalate levels in non-primary hyperoxaluria patients with raised plasma oxalate levels who are receiving maintenance haemodialysis.
2 secondary outcomes
Absolute change in pre-dialysis mean plasma
Time frame: Baseline to month 3-6,
Side effects (tolerability)
Time frame: Monthly - month 0-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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.
Gerlineke MC Hawkins-van der Cingel, MBBS contact
Felix Knauf, MD principal investigator
Charite Universitätsmedizin
1 site in 1 country: 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 Haemodialysis and Chronic Kidney Disease Requiring Chronic Dialysis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerlineke MC Hawkins-van der Cingel, MBBS (+ 49 030 450 530067, gerlineke.hawkins-van-der-cingel@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-dialysis Plasma Oxalate concentration (time frame: It will be measured at baseline and month 1-6 (weeks 4, 8, 12, 16, 20 and 24).). 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 21 Aug 2024.