Daratumumab in Treatment of PGNMID and C3 GN

NCT03095118 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-004805
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Membranoproliferative Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (8)

• Remission Status at 6 Months

  6 months

• Remission Status at 12 Months

  12 months

• Proteinuria at Baseline

  Baseline

• Proteinuria at 6 Months

  6 months

• Proteinuria at 12 Months

  12 months

Study Arms (1)

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

Drug: Daratumumab

Interventions

Daratumumab DRUG

Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses

Also known as: Darzalex

Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fernando Fervenza: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 33685975 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glomerulonephritis, Membranoproliferative

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Fernando C. Fervenza
• Organization: Mayo Clinic

Fervenza.Fernando@mayo.edu

507-266-1045

Study Officials

• Fernando C Fervenza, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 29, 2017
• Study Start: September 7, 2017
• Primary Completion: October 14, 2019
• Study Completion: May 12, 2020
• Last Updated: August 31, 2022
• Results First Posted: July 16, 2021

Record last verified: 2022-08

Locations

US (1)