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Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00498368
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : November 18, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborators:
Ohio State University
Stanford University
University of North Carolina, Chapel Hill
Columbia University
Genentech, Inc.
Biogen
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition IgA Nephropathy
Interventions Drug: Intravenous Rituximab
Drug: ACE/ARB
Dietary Supplement: Omega-3 Fatty Acid Fish Oil Supplement
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 17 17
Completed 14 15
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             3             2
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
43
(29 to 63)
33
(21 to 59)
40
(21 to 63)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
7
  41.2%
2
  11.8%
9
  26.5%
Male
10
  58.8%
15
  88.2%
25
  73.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title Change in Proteinuria at 12 Months
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants differs from the participant flow because not all participants had the laboratory test done.
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
Number of participants with > 50% reduction 3 3
Number of participants with >50% increase 1 2
Number of participants with <500 mg of protein 2 2
2.Secondary Outcome
Title Biochemical Marker IgA at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants differs from the participant flow because not all participants had the laboratory test done.
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mg/ml
4.4  (1.4) 4.6  (1.9)
3.Secondary Outcome
Title Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants differs from the participant flow because not all participants had the laboratory test done.
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: U/100ng IgA
60.5  (13.0) 58.9  (5.6)
4.Secondary Outcome
Title Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants differs from the participant flow because not all participants had the laboratory test done.
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: U/ml
1751.3  (2469.4) 1075  (908.7)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab Plus ACE/ARB ACE/ARB
Hide Arm/Group Description

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 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

All-Cause Mortality
Rituximab Plus ACE/ARB ACE/ARB
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Rituximab Plus ACE/ARB ACE/ARB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab Plus ACE/ARB ACE/ARB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Fernando Fervenza
Organization: Mayo Clinic
Phone: 507-255-3712
EMail: Fervenza.Fernando@mayo.edu
Layout table for additonal information
Responsible Party: Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00498368    
Other Study ID Numbers: 07-001944
First Submitted: July 9, 2007
First Posted: July 10, 2007
Results First Submitted: September 28, 2016
Results First Posted: November 18, 2016
Last Update Posted: February 1, 2017