Trial Outcomes & Findings for Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy (NCT NCT00498368)

NCT ID: NCT00498368

Last Updated: 2017-02-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-02-01

Participant Flow

Participant milestones

Measure	Rituximab Plus ACE/ARB Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Overall Study STARTED	17	17
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Rituximab Plus ACE/ARB Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

Baseline characteristics by cohort

Measure	Rituximab Plus ACE/ARB n=17 Participants Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB n=17 Participants ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	Total n=34 Participants Total of all reporting groups
Age, Continuous	43 years n=5 Participants	33 years n=7 Participants	40 years n=5 Participants
Gender Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Gender Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The number of participants differs from the participant flow because not all participants had the laboratory test done.

Outcome measures

Measure	Rituximab Plus ACE/ARB n=10 Participants Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB n=10 Participants ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Change in Proteinuria at 12 Months Number of participants with > 50% reduction	3 participants	3 participants
Change in Proteinuria at 12 Months Number of participants with >50% increase	1 participants	2 participants
Change in Proteinuria at 12 Months Number of participants with <500 mg of protein	2 participants	2 participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants differs from the participant flow because not all participants had the laboratory test done.

Outcome measures

Measure	Rituximab Plus ACE/ARB n=10 Participants Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB n=10 Participants ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Biochemical Marker IgA at 12 Months	4.4 mg/ml Standard Deviation 1.4	4.6 mg/ml Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants differs from the participant flow because not all participants had the laboratory test done.

Outcome measures

Measure	Rituximab Plus ACE/ARB n=10 Participants Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB n=10 Participants ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months	60.5 U/100ng IgA Standard Deviation 13.0	58.9 U/100ng IgA Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants differs from the participant flow because not all participants had the laboratory test done.

Outcome measures

Measure	Rituximab Plus ACE/ARB n=10 Participants Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement Intravenous Rituximab: Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182 * An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of \<130/80 millimeters of mercury Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day	ACE/ARB n=10 Participants ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of \<130/80 millimeters of mercury (mmHg) Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months	1751.3 U/ml Standard Deviation 2469.4	1075 U/ml Standard Deviation 908.7

Adverse Events

Rituximab Plus ACE/ARB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACE/ARB

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. Fernando Fervenza

Mayo Clinic

Phone: 507-255-3712

Email: Fervenza.Fernando@mayo.edu

Results disclosure agreements

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