Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune 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
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
Treatments tested in this trial
- Daratumumab
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
4Mayo Clinic32224, JacksonvilleFlorida, United States
Mayo Clinic55905, RochesterMinnesota, United States
University North Carolina at Chapel Hill27599, Chapel HillNorth Carolina, United States
Oregon Health and Science University97239, PortlandOregon, United States
Sponsors and collaborators
Mayo Clinic
Lead sponsor
Source ClinicalTrials.gov