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Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00498368
First received: July 9, 2007
Last updated: December 6, 2016
Last verified: December 2016
History of Changes
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: IgA Nephropathy
Interventions: Drug: Intravenous Rituximab
Drug: ACE/ARB
Dietary Supplement: Omega-3 Fatty Acid Fish Oil Supplement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Rituximab Plus ACE/ARB   ACE/ARB
STARTED   17   17 
COMPLETED   14   15 
NOT COMPLETED   3   2 
Withdrawal by Subject                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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

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 Total of all reporting groups

Baseline Measures
   Rituximab Plus ACE/ARB   ACE/ARB   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 17   17   34 
Age 
[Units: Years]
Median (Full Range) 		 43 
 (29 to 63)  		 33 
 (21 to 59)  		 40 
 (21 to 63) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      7  41.2%      2  11.8%      9  26.5% 
Male      10  58.8%      15  88.2%      25  73.5% 
Region of Enrollment 
[Units: Participants]
 		     
United States   17   17   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Proteinuria at 12 Months   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Biochemical Marker IgA at 12 Months   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months   [ Time Frame: 12 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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Time Frame 12 months
Additional Description No text entered.

Reporting Groups
  Description
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

Serious Adverse Events
    Rituximab Plus ACE/ARB   ACE/ARB
Total, Serious Adverse Events     
# participants affected / at risk   0/17 (0.00%)   0/17 (0.00%) 




  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr. Fernando Fervenza
Organization: Mayo Clinic
phone: 507-255-3712
e-mail: Fervenza.Fernando@mayo.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00498368     History of Changes
Other Study ID Numbers: 07-001944
Study First Received: July 9, 2007
Results First Received: September 28, 2016
Last Updated: December 6, 2016