Trial Outcomes & Findings for Pilot Study of Velcade® in IgA Nephropathy (NCT NCT01103778)

NCT ID: NCT01103778

Last Updated: 2018-11-16

Results Overview

Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline and 1 year
• Results posted on: 2018-11-16

Participant Flow

Participant milestones

Measure	Velcade Arm Single treatment arm: Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Velcade Arm Single treatment arm: Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Overall Study Lost to Follow-up	1
Overall Study Proteinuria improved prior to enrollment	1
Overall Study Screen failure	1

Baseline Characteristics

Pilot Study of Velcade® in IgA Nephropathy

Baseline characteristics by cohort

Measure	Velcade® Therapy n=8 Participants Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Population: 1 participant was lost to followup.

Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

Outcome measures

Measure	Velcade® Therapy n=7 Participants Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Proteinuria Baseline	2.52 grams per 24 hrs Interval 1.17 to 4.96
Proteinuria 1 year	1.43 grams per 24 hrs Interval 0.1 to 4.23

PRIMARY outcome

Timeframe: 1 year

Population: 1 participant was lost to followup.

Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection.

Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection.

Outcome measures

Measure	Velcade® Therapy n=7 Participants Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Number of Participants With Complete Remission, Partial Response, or no Response. Complete Remission	3 Participants
Number of Participants With Complete Remission, Partial Response, or no Response. Partial Response	1 Participants
Number of Participants With Complete Remission, Partial Response, or no Response. No Response	3 Participants

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: 1 participant lost to followup.

Preservation of renal function will be assessed.

Outcome measures

Measure	Velcade® Therapy n=7 Participants Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Serum Creatinine Baseline	1.35 milligram per deciliter Interval 0.54 to 2.63
Serum Creatinine 1 year	1.52 milligram per deciliter Interval 0.52 to 2.75

SECONDARY outcome

Timeframe: 1 year

Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.

Outcome measures

Measure	Velcade® Therapy n=8 Participants Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.	1 Participants

Adverse Events

Velcade® Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Velcade® Therapy n=8 participants at risk Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Blood and lymphatic system disorders Mild reversible decline platelet count	12.5% 1/8 • Number of events 1 • 1 year

Additional Information

Dr. Choli Hartono

Rogosin Institute

Phone: 212-746-1578

Email: chh2001@nyp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place