Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits (NCT05654506) | Clinical Trial Compass
RecruitingPhase 2
Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits
United States40 participantsStarted 2023-08-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* A woman must agre…