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Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

This study has been terminated.
(DSMB recommended stopping the trial because of lack of effect.)
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT00318474
First received: April 24, 2006
Last updated: February 4, 2016
Last verified: February 2016
Results First Received: June 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: IgA Nephropathy
Interventions: Drug: Mycophenolate Mofetil (MMF)
Drug: MMF Placebo
Drug: ACEi
Drug: FOS

  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
184 subjects were enrolled. 146 subjects completed entry evaluation. 97 subjects fulfilled entry criteria and were started on 3 month course of Omacor and lisinopril. 94 subjects completed the 3 months of treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After the 3 months, 58 subjects fulfilled criteria for going into the MMF vs. placebo phase. Six of the 58 subjects were not randomized because the External Advisory Committee/Data Safety Monitoring Board recommended stopping the trial because of lack of effect.

Reporting Groups
  Description
Mycophenolate Mofetil (MMF)

Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.

Mycophenolate Mofetil (MMF)

Placebo Subjects receive ACEi and FOS and placebo.

Participant Flow:   Overall Study
    Mycophenolate Mofetil (MMF)   Placebo
STARTED   25   27 
COMPLETED   7   10 
NOT COMPLETED   18   17 
Adverse Event                1                1 
Lost to Follow-up                0                1 
Pregnancy                0                2 
Protocol Violation                1                0 
Withdrawal by Subject                3                2 
Fall in GFR                3                3 
Post-therapy hyperflycemia                0                1 
Trial terminated                10                7 



  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
Mycophenolate Mofetil (MMF)

Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.

Mycophenolate Mofetil (MMF)

Placebo Subjects receive ACEi and FOS and placebo.
Total Total of all reporting groups

Baseline Measures
   Mycophenolate Mofetil (MMF)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   27   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.8  (11.7)   32.2  (13.2)   32.0  (12.2) 
Age 
[Units: Participants]
     
<=18 years   5   6   11 
Between 18 and 65 years   20   21   41 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   11   9   20 
Male   14   18   32 
Region of Enrollment 
[Units: Participants]
     
United States   19   23   42 
Canada   6   4   10 


  Outcome Measures

1.  Primary:   Change in Proteinuria - Uprotein/Creatinine Ratio   [ Time Frame: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo. ]

2.  Secondary:   Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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: Ron Hogg, M.D.
Organization: Saint Joseph's Hospital and Medical Center
phone: 602-406-3246
e-mail: ronhogg@gmail.com



Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT00318474     History of Changes
Other Study ID Numbers: 04PE116
IND #48,977 ( Other Identifier: Food and Drug Administration )
Canadian Control #076948 ( Other Identifier: Bureau of Pharmaceutical Assessment - Canada )
Study First Received: April 24, 2006
Results First Received: June 3, 2014
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada