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Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT00318474
Recruitment Status : Terminated (DSMB recommended stopping the trial because of lack of effect.)
First Posted : April 26, 2006
Results First Posted : October 1, 2014
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition IgA Nephropathy
Interventions Drug: Mycophenolate Mofetil (MMF)
Drug: MMF Placebo
Drug: ACEi
Drug: FOS
Enrollment 184
Recruitment Details 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 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.
Arm/Group Title Mycophenolate Mofetil (MMF) Placebo
Hide Arm/Group Description

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)

Subjects receive ACEi and FOS and placebo.
Period Title: Overall Study
Started 25 27
Completed 7 10
Not Completed 18 17
Reason Not Completed
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
Arm/Group Title Mycophenolate Mofetil (MMF) Placebo Total
Hide Arm/Group Description

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)

Subjects receive ACEi and FOS and placebo. Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
31.8  (11.7) 32.2  (13.2) 32.0  (12.2)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
<=18 years
5
  20.0%
6
  22.2%
11
  21.2%
Between 18 and 65 years
20
  80.0%
21
  77.8%
41
  78.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
11
  44.0%
9
  33.3%
20
  38.5%
Male
14
  56.0%
18
  66.7%
32
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
United States 19 23 42
Canada 6 4 10
1.Primary Outcome
Title Change in Proteinuria - Uprotein/Creatinine Ratio
Hide Description Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolate Mofetil (MMF) Placebo
Hide Arm/Group Description:

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)

Subjects receive ACEi and FOS and placebo.
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: ratio
1.40  (0.72) 1.58  (1.07)
2.Secondary Outcome
Title Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame The trial design is 13 visits over 27 months.
Adverse Event Reporting Description Adverse events assessed at each encounter with subject.
 
Arm/Group Title Mycophenolate Mofetil (MMF) Placebo
Hide Arm/Group Description

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)

Subjects receive ACEi and FOS and placebo.
All-Cause Mortality
Mycophenolate Mofetil (MMF) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mycophenolate Mofetil (MMF) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      1/27 (3.70%)    
General disorders     
trauma * [1]  1/25 (4.00%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
melanoma   0/25 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
motor vehicle accident (mva)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mycophenolate Mofetil (MMF) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/25 (100.00%)      27/27 (100.00%)    
Gastrointestinal disorders     
diarrhea   4/25 (16.00%)  6/27 (22.22%) 
heartburn   5/25 (20.00%)  2/27 (7.41%) 
nausea   8/25 (32.00%)  4/27 (14.81%) 
General disorders     
edema   5/25 (20.00%)  3/27 (11.11%) 
Infections and infestations     
sore throat   1/25 (4.00%)  7/27 (25.93%) 
Musculoskeletal and connective tissue disorders     
backache   6/25 (24.00%)  6/27 (22.22%) 
Respiratory, thoracic and mediastinal disorders     
common cold   5/25 (20.00%)  7/27 (25.93%) 
coughing   9/25 (36.00%)  9/27 (33.33%) 
upper respiratory infection   5/25 (20.00%)  5/27 (18.52%) 
Indicates events were collected by systematic assessment
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
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 )
First Submitted: April 24, 2006
First Posted: April 26, 2006
Results First Submitted: June 3, 2014
Results First Posted: October 1, 2014
Last Update Posted: March 7, 2016