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Proliferative Glomerulonephritis With Monoclonal IgG DepositsPhase 2NCT05654506

Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits

A Phase 2 study testing Daratumumab in people with Proliferative Glomerulonephritis With Monoclonal IgG Deposits, run by Mayo Clinic at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in people with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID). Read more about this study

Who is it for?
Ages 18 years and older
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
40 participants
Where
4 sitesUnited States
Study dates
17 Aug 2023to Aug 2028
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

  • Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID
  • Proteinuria ≥ 1000 mg over 24 hours
  • Creatinine clearance ≥ 20 mL/min/SA
  • Subjects able and willing to give informed consent
  • For female subjects of reproductive childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the Treatment Period, during any dose interruptions, and for 3 months after the last dose of any component of the treatment regimen. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. This birth control method must include one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
  • A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing.
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  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen.
  • For male subjects of reproductive potential who are sexually active with females of
  • reproductive potential must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even after a successful vasectomy).
  • Male subjects of reproductive potential must not donate sperm during the study or for 3 months after the last dose of study treatment.
  • Must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Who cannot join

  • Pregnant or planning to become pregnant
  • Seropositive for human immunodeficiency virus (HIV)
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) will also be excluded. Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR and can be included.
  • Multiple myeloma defined as >10% plasma cells on bone marrow biopsy and M-spike > 3 g/dL and presence of myeloma defining event (hypercalcemia, cast nephropathy, bone disease, or anemia), or plasma cells >60% or FLC ratio of involved to uninvolved > 100
  • Abnormal clinical labs defined as: anemia with Hgb < 8.0 g/dL, thrombocytopenia with platelet count < 75,000, leukopenia with WBC < 3.5, or neutropenia with ANC < 1000, AST/ALT > 2.5 X ULN, bilirubin > 2 X ULN
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  • Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal.
  • Moderate or severe persistent asthma withing the past 2 years or uncontrolled asthma of any classification. Note the participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
  • Clinically significant cardiac disease including:
  • Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to cardiac dysfunction (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)
  • Uncontrolled arrythmia
  • Prior or current exposure to any of the following:
  • To daratumumab or other anti-CD-38 therapies (unless a re-treatment study)
  • Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.
  • Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
  • 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 4 weeks. Patients treated with low dose oral prednisone or glucocorticoid are allowed to be included if they are taking the medication for conditions unrelated to PGNMID (e.g., asthma, gout) at a daily dose of 10mg or less.
  • Patients who had received immunosuppressive therapy with MMF, cyclosporine, tacrolimus, or azathioprine in the last 3 months. For patients who have shown no reduction in proteinuria despite ≥ 3 months of MMF, AZA, cyclosporine, tacrolimus, etc, are allowed to enter the study after discontinuing these meds for 7 or more days.
  • Patients who have received cyclophosphamide or bortezomib will be allowed to participate as long as there is clear evidence of lack of response to cyclophosphamide or bortezomib defined as lack of achieving complete or partial remission.
  • Patients who received rituximab previously with CD20 count of < 20 cells/microliter at the time of enrollment
  • Have received vaccination with live attenuated vaccines within 4 weeks of first study agent administration
  • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease before the date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Multi-center Open-label Trial Evaluating the Efficacy and Safety of Daratumumab SC in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits (PGNMID)

The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in people with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID).

Being tested
Daratumumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    1800 mg subcutaneous (SC) injection (total amount 15 mL) into the right/left abdominal area once weekly for 8 doses followed by once every 2 weeks for an additional 8 doses

Study groups in NCT05654506
Study groupRoleWhat they receive
Daratumumab treatment in PGNMIDExperimentalSubjects with native kidney biopsy consistent with membranoproliferative glomerulonephritis with monoclonal immunoglobulin deposits will receive daratumumab.
Receives: Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in proteinuria

    Change in protein in the urine from baseline to 12 months of follow-up

    Measured: Baseline, 12 months

Secondary outcomes (11)

  1. Number of Treatment-Emergent Adverse Events

    Number of treatment-emergent adverse events as defined as major infection (defined as those requiring ED visit or hospitalization for development of pneumonia, sepsis, severe UTI or pyelonephritis, meningitis and c.diff infections), grade 3 or 4 anemia, leukopenia, thrombocytopenia, neutropenia or hospitalization due to eye complication.

    Measured: 12 months

  2. Proteinuria at 6 Months

    Measured using 24 hour urine collection reported in mg/24 h

    Measured: 6 months

  3. Serum Albumin at 6 months

    Blood serum collected and reported in g/dL

    Measured: 6 months

  4. Serum Albumin at 12 months

    Blood serum collected and reported in g/dL

    Measured: 12 months

  5. Serum Creatinine at 6 Months

    Blood serum collected and reported in mg/dL

    Measured: 6 months

  6. Serum Creatinine at 12 Months

    Blood serum collected and reported in mg/dL

    Measured: 12 months

  7. Hematuria at 6 months

    Measured by urinalysis (urine testing) reported in red blood cells per high power field (RBC/HPF)

    Measured: 6 months

  8. Hematuria at 12 months

    Measured by urinalysis (urine testing) reported in red blood cells per high power field (RBC/HPF)

    Measured: 12 months

  9. Complete remission status

    Number of subjects to achieve complete remission at 12 months defined as < 500 mg proteinuria/24 hours and no than a 15% reduction in GFR as determined by creatinine clearance

    Measured: 12 months

  10. Partial remission status

    Number of subjects to achieve partial remission status at 12 months defined as > 50% reduction in 24-hour proteinuria and no greater than a 30% reduction in baseline GFR as determined by creatinine clearance

    Measured: 12 months

  11. Maintenance of remission

    Number of subjects to maintain their remission status at 24 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start17 Aug 2023
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654506
Sponsor's protocol ID
22-002587
Status last verified
Sep 2026
First submitted
8 Dec 2022
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab in people with Proliferative Glomerulonephritis With Monoclonal IgG Deposits, run by Mayo Clinic at 4 sites 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 11 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 8 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 4 sites 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?

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?

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?

Change in proteinuria (time frame: Baseline, 12 months). 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 NCT05654506.

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 8 Sep 2026.

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