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Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits

ConditionProliferative Glomerulonephritis With Monoclonal IgG Deposits
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Daratumumab

    Drug

    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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Daratumumab treatment in PGNMIDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in proteinuria

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

Time frame
Baseline, 12 months

Secondary outcomes

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.

Time frame
12 months
2

Proteinuria at 6 Months

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

Time frame
6 months
3

Serum Albumin at 6 months

Blood serum collected and reported in g/dL

Time frame
6 months
4

Serum Albumin at 12 months

Blood serum collected and reported in g/dL

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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