Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

Overview

Información sobre este estudio

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?

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Stephen Erickson, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20119097

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