Trial Outcomes & Findings for Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis (NCT NCT02197767)

Results Overview

Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Day 0, Day 365

Results posted on

2019-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. rituximab: 1000 mg infusion
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=11 Participants rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. rituximab: 1000 mg infusion
Age, Continuous	58.5 years STANDARD_DEVIATION 2.03 • n=11 Participants
Sex: Female, Male Female	8 Participants n=11 Participants
Sex: Female, Male Male	3 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: Day 0, Day 365

Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).

Outcome measures

Outcome measures
Measure	Rituximab n=11 Participants rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. rituximab: 1000 mg infusion
Change in 24 Hour Creatinine Clearance	41.0 mL/min/SA Standard Deviation 15.52

SECONDARY outcome

Timeframe: Day 0, Day 365

Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.

Outcome measures

Outcome measures
Measure	Rituximab n=11 Participants rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. rituximab: 1000 mg infusion
Change in Proteinuria	2589.8 mg Standard Deviation 1741.5

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen B. Erickson

Mayo Clinic

Phone: 507-284-4083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place