Kidney FailurePhase 2DAMOCLESNCT06889948
The Effect of Daratumumab in Patients With Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
A Phase 2 study testing Daratumumab in people with Kidney Failure and Paraproteinemias, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Paraproteinemias, Glomerulonephritis
- What is being tested?
- Daratumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 19 Jan 2024to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Males or females ≥ 18 years of age
- Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- Renal biopsy confirmed MGRS-disease
- Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted.
- Renal transplant patients are allowed
- Amount of proteinuria ≥ 500 mg/24 h OR eGFR ≥ 20 ml/min prior to the study
- Previous anticlonal treatment is allowed if deemed ineffective
Who cannot join
- Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)
- Cancer that requires treatment,
- MGRS related to B-cell malignant disorders,
- Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),
- Pregnancy or breastfeeding,
- Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;
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- prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.
- mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.
- In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required.
- Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and/or hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kati Kaartinen, PhD contact
About this study
Official title: Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland
The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS).
The main questions it aims to answer are:
Read more
Does daratumumab have an effect on the patients' renal function or the amount of proteinuria?
Does daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)?
Also changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.
- Conditions
- Kidney Failure, Paraproteinemias, Glomerulonephritis
- Being tested
- Daratumumab
- Keywords
- Monoclonal gammopathy of renal significance, daratumumab
- Medical subject headings
- Renal Insufficiency, Paraproteinemias, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab as a single agent therapy | Active comparator | Daratumumab Receives: Drug: Daratumumab |
| Daratumumab combined with stem cell transplantation | Active comparator | Daratumumab in combination with stem cell transplantation Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete renal remission or partial renal remission and proteinuria and eGFR at EOT.
Complete renal remission (proteinuria <500 mg/d and <15% decline in baseline eGFR) Partial renal remission (>50% reduction in 24-h proteinuria and < 30% decline in eGFR)
Measured: Through study completion, an average of 12 to 18 months
Secondary outcomes (8)
Rate of complete renal remission or partial renal remission and proteinuria and eGFR after 6 cycles of daratumumab.
Complete renal remission (proteinuria <500 mg/d and <15% decline in baseline eGFR) Partial renal remission (>50% reduction in 24-h proteinuria and < 30% decline in eGFR)
Measured: At the end of daratumumab treatment cycle 6 (each cycle is 28 days)
Rate of negativity of bone marrow minimal residual disease (MRD) after 6 and 12 cycles of daratumumab.
Measured: At the end of cycle 6 (each cycle is 28 days) and through study completion, an average of 12 to 18 months
Number of patients with complement dysregulation-mediated renal damage caused by paraprotein.
Measured: Through study completion, an average of 12 to 18 months
Number of patients in end-stage renal disease or with eGFR decline > 50 %.
Measured: Through study completion, an average of 12 to 18 months
Number of patients with proteinuria decline < 25 %.
Measured: Through study completion, an average of 12 to 18 months
Number of patients with complete or partial or very good partial hematological remission
Measured: Through study completion, an average of 12 to 18 months
Number of patients with serious adverse events (SAE)
Measured: Through study completion, an average of 12 to 18 months
Number of patients with significant adverse events (AE)
Measured: Through study completion, an average of 12 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, L.P. - Investigator Initiated Studies Program
- Responsible party
- Principal investigator, Minna Seppälä, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889948
- Sponsor's protocol ID
- 20221
- Other IDs
- 2021-005856-12
- Acronym
- DAMOCLES
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland
- ClinicalTrials.gov ID
- NCT06889948
- Acronym / sponsor ID
- DAMOCLES / 20221
- Conditions
- Kidney Failure, Paraproteinemias, Glomerulonephritis
- Keywords
- Monoclonal gammopathy of renal significance, daratumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Janssen, L.P. - Investigator Initiated Studies Program
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Mar 2025 (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.
The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS).
The main questions it aims to answer are:
Does daratumumab have an effect on the patients' renal function or the amount of proteinuria?
Does daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)?
Also changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.
| Arm | Type | Receives |
|---|---|---|
| Daratumumab as a single agent therapy | Active comparator | Drug: DaratumumabDaratumumab |
| Daratumumab combined with stem cell transplantation | Active comparator | Drug: DaratumumabDaratumumab in combination with stem cell transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females ≥ 18 years of age
- Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- Renal biopsy confirmed MGRS-disease
- Amount of proteinuria ≥ 500 mg/24 h OR eGFR ≥ 20 ml/min prior to the study
- Previous anticlonal treatment is allowed if deemed ineffective
Key exclusion criteria (10 listed)
- Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)
- Cancer that requires treatment,
- MGRS related to B-cell malignant disorders,
- Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),
- Pregnancy or breastfeeding,
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 |
|---|---|---|
| DaratumumabAll patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation. | Drug | Daratumumab as a single agent therapy, Daratumumab combined with stem cell transplantation |
Primary outcome
Rate of complete renal remission or partial renal remission and proteinuria and eGFR at EOT.
Time frame: Through study completion, an average of 12 to 18 months
Complete renal remission (proteinuria <500 mg/d and <15% decline in baseline eGFR) Partial renal remission (>50% reduction in 24-h proteinuria and < 30% decline in eGFR)
8 secondary outcomes
Rate of complete renal remission or partial renal remission and proteinuria and eGFR after 6 cycles of daratumumab.
Time frame: At the end of daratumumab treatment cycle 6 (each cycle is 28 days)
Rate of negativity of bone marrow minimal residual disease (MRD) after 6 and 12 cycles of daratumumab.
Time frame: At the end of cycle 6 (each cycle is 28 days) and through study completion, an average of 12 to 18 months
Number of patients with complement dysregulation-mediated renal damage caused by paraprotein.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients in end-stage renal disease or with eGFR decline > 50 %.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with proteinuria decline < 25 %.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with complete or partial or very good partial hematological remission
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with serious adverse events (SAE)
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with significant adverse events (AE)
Time frame: Through study completion, an average of 12 to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kati Kaartinen, PhD contact
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 Daratumumab in people with Kidney Failure and Paraproteinemias, run by Helsinki University Central Hospital at 1 site in Finland.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 Finland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minna Seppälä, MD (+358 50 427 1087, minna.seppala@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete renal remission or partial renal remission and proteinuria and eGFR at EOT. (time frame: Through study completion, an average of 12 to 18 months). 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 16 Sep 2026.