Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

Overview

About this study

Will use of Rituximab reduce proteinuria over a 12 month period and will there be preservation of kidney function with the use of this study drug?

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of Fibrillary Glomerulonephritis
  • Proteinuria > 1 gram
  • Patients need to be treated with an ACEi and/or ARB, for at least 3 months prior to enrollment
  • BP< 140/90 mmHg in >75% of readings
  • Women must be post menopausal, surgically sterile, or practicing a medically approved method of contraception
  • Able and willing to give written informed consent and comply with the requirements of the study protocol
  • eGFR greater than or equal to 25 mL/ min using CKD EPI formula or a quantified creatinine clearance > 25mL/ min and/or serum creatinine <3.0 mg/dL
  • Negative chest x-ray within one year
  • Negative serum pregnancy test for women of child bearing age
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 12 months after completion of treatment
  • Total bilirubin, AST, ALT, and alkaline phosphatase levels <2 times the upper limit of normal
  • Hemoglobin >7.0 gm/dL, white count >3.0 X 10(9), platelet count >100 X 10(9)

Exclusion Criteria:

  • History of HIV
  • Presence of active infection
  • New York Hear Association Classification III or IV heart disease
  • Concomitant malignancies or previous malignancies within the last 5 years
  • History of psychiatric disorder
  • At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to treatment
  • Positive hepatitis B or C serology is considered a potential exclusion criterion. For inclusion into the study, the patient must have a negative HBsAg and anti-HBc lab value within 1 year of signing consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Erickson, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

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