Membranoproliferative GlomerulonephritisPhase 2NCT03095118
Daratumumab in Treatment of PGNMID and C3 GN
A Phase 2 study testing Daratumumab in people with Membranoproliferative Glomerulonephritis, run by Fernando Fervenza at 1 site in United States.
Trial summary
This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Membranoproliferative Glomerulonephritis
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 12 May 2020
- 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
- Age ≥ 18 years of age
- Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID or C3 GN
- In cases of C3GN serum electrophoresis with immunofixation should confirm presence of monoclonal gammopathy
- Proteinuria ≥ 1000 mg over 24 hours
- eGFR ≥ 20 mL/min/SA
- Subjects able and willing to give informed consent
Who cannot join
- Pregnancy
- Hepatitis B or C, HIV
- Multiple myeloma
- Anemia with Hgb < 8.5 g/dL
- Thrombocytopenia with platelet count < 100,000
- Leukopenia with WBC < 3.5
Show all 11Show fewer
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
- Unable to provide consent
- Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the last 6 weeks
- Patients who had received immunosuppressive therapy including cyclophosphamide, MMF, cyclosporine, tacrolimus or azathioprine in the last 3 months
- Patients who received rituximab previously with CD20 count of zero at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy
This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease in the kidney due to the production of abnormal proteins. There are no known standard effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy. These diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal proteins from abnormal clones. Everyone in this study will receive daratumumab.
Read the detailed description
This study is an open-label phase 2 trial of the safety and efficacy of daratumumab, in the treatment of PGNMID and C3GN associated with monoclonal gammopathy. Subjects will be screened at outpatient Nephrology Clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. Daratumumab will be administered once weekly for 8 weeks and then once every 2 weeks for 8 additional doses. Patients will be followed for a total of 12 months (6 months after the last infusion). A final visit for evaluation and collection of lab samples will be conducted at the end of the study.
- Conditions
- Membranoproliferative Glomerulonephritis
- Being tested
- Daratumumab
- Medical subject headings
- Glomerulonephritis, Membranoproliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called Darzalex
Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab | Experimental | Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events
Number of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.
Measured: 1 year
Secondary outcomes (8)
Remission Status at 6 Months
The number of subjects to reach either complete remission or partial remission at 6 months after infusion.
Measured: 6 months
Remission Status at 12 Months
The number of subjects to reach either complete remission or partial remission at 12 months after infusion.
Measured: 12 months
Proteinuria at Baseline
Measured using 24 hour urine collection reported in mg/24h
Measured: Baseline
Proteinuria at 6 Months
Measured using 24 hour urine collection reported in mg/24 h
Measured: 6 months
Proteinuria at 12 Months
Measured using 24 hour urine collection reported in mg/24h
Measured: 12 months
Serum Creatinine at Baseline
Blood serum collected and reported in mg/dL
Measured: Baseline
Serum Creatinine at 6 Months
Blood serum collected and reported in mg/dL
Measured: 6 months
Serum Creatinine at 12 Months
Blood serum collected and reported in mg/dL
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start7 Sep 2017
- Primary completion14 Oct 2019
- Study completion12 May 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Membranoproliferative GlomerulonephritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernando Fervenza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernando Fervenza, Mayo Clinic
- Investigators
- Fernando C Fervenza, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095118
- Sponsor's protocol ID
- 16-004805
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2017
- Last updated
- 31 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zand L, Rajkumar SV, Leung N, Sethi S, El Ters M, Fervenza FC. Safety and Efficacy of Daratumumab in Patients with Proliferative GN with Monoclonal Immunoglobulin Deposits. J Am Soc Nephrol. 2021 May 3;32(5):1163-1173. doi: 10.1681/ASN.2020101541. Epub 2021 Mar 8.
PubMed 33685975
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy
- ClinicalTrials.gov ID
- NCT03095118
- Acronym / sponsor ID
- 16-004805
- Conditions
- Membranoproliferative Glomerulonephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fernando FervenzaUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease in the kidney due to the production of abnormal proteins. There are no known standard effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy. These diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal proteins from abnormal clones. Everyone in this study will receive daratumumab.
Detailed description
This study is an open-label phase 2 trial of the safety and efficacy of daratumumab, in the treatment of PGNMID and C3GN associated with monoclonal gammopathy. Subjects will be screened at outpatient Nephrology Clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. Daratumumab will be administered once weekly for 8 weeks and then once every 2 weeks for 8 additional doses. Patients will be followed for a total of 12 months (6 months after the last infusion). A final visit for evaluation and collection of lab samples will be conducted at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daratumumab | Experimental | Drug: DaratumumabSubjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years of age
- Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID or C3 GN
- In cases of C3GN serum electrophoresis with immunofixation should confirm presence of monoclonal gammopathy
- Proteinuria ≥ 1000 mg over 24 hours
- eGFR ≥ 20 mL/min/SA
Key exclusion criteria (11 listed)
- Pregnancy
- Hepatitis B or C, HIV
- Multiple myeloma
- Anemia with Hgb < 8.5 g/dL
- Thrombocytopenia with platelet count < 100,000
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 |
|---|---|---|
| DaratumumabAlso: DarzalexIntravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses | Drug | Daratumumab |
Primary outcome
Number of Treatment-Emergent Adverse Events
Time frame: 1 year
Number of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.
8 secondary outcomes
Remission Status at 6 Months
Time frame: 6 months
Remission Status at 12 Months
Time frame: 12 months
Proteinuria at Baseline
Time frame: Baseline
Proteinuria at 6 Months
Time frame: 6 months
Proteinuria at 12 Months
Time frame: 12 months
Serum Creatinine at Baseline
Time frame: Baseline
Serum Creatinine at 6 Months
Time frame: 6 months
Serum Creatinine at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33685975Zand L, Rajkumar SV, Leung N, Sethi S, El Ters M, Fervenza FC. Safety and Efficacy of Daratumumab in Patients with Proliferative GN with Monoclonal Immunoglobulin Deposits. J Am Soc Nephrol. 2021 May 3;32(5):1163-1173. doi: 10.1681/ASN.2020101541. Epub 2021 Mar 8.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Membranoproliferative Glomerulonephritis
Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
Not yet recruitingObservational study
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
Glomerulopathy, C3G
RecruitingObservational study
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
Complement 3 Glomerulopathy
RecruitingPhase 4
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
RecruitingPhase 2
Chinese Adults With Kidney Disease
Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G)
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.
Fernando C Fervenza, MD principal investigator
Mayo Clinic
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 Membranoproliferative Glomerulonephritis, run by Fernando Fervenza at 1 site in United States.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 31 Aug 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2021). 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?
Number of Treatment-Emergent Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095118, which also lists 1 linked publication.
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 31 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.