Trial Outcomes & Findings for Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (NCT NCT00318474)

NCT ID: NCT00318474

Last Updated: 2016-03-07

Results Overview

Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 184 participants
• Primary outcome timeframe: 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.
• Results posted on: 2016-03-07

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	25	27
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	18	17

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	0	1
Overall Study Pregnancy	0	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	3	2
Overall Study Fall in GFR	3	3
Overall Study Post-therapy hyperflycemia	0	1
Overall Study Trial terminated	10	7

Baseline Characteristics

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Baseline characteristics by cohort

Measure	Mycophenolate Mofetil (MMF) n=25 Participants 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 n=27 Participants Subjects receive ACEi and FOS and placebo.	Total n=52 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 11.7 • n=5 Participants	32.2 years STANDARD_DEVIATION 13.2 • n=7 Participants	32.0 years STANDARD_DEVIATION 12.2 • n=5 Participants
Age, Categorical <=18 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	23 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.

Outcome measures

Measure	Mycophenolate Mofetil (MMF) n=25 Participants 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 n=27 Participants Subjects receive ACEi and FOS and placebo.
Change in Proteinuria - Uprotein/Creatinine Ratio	1.40 ratio Standard Deviation 0.72	1.58 ratio Standard Deviation 1.07

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Mycophenolate Mofetil (MMF)

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mycophenolate Mofetil (MMF) n=25 participants at risk 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 n=27 participants at risk Subjects receive ACEi and FOS and placebo.
Skin and subcutaneous tissue disorders melanoma	0.00% 0/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	3.7% 1/27 • Number of events 1 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
General disorders trauma	4.0% 1/25 • Number of events 1 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	0.00% 0/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.

Other adverse events

Measure	Mycophenolate Mofetil (MMF) n=25 participants at risk 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 n=27 participants at risk Subjects receive ACEi and FOS and placebo.
Musculoskeletal and connective tissue disorders backache	24.0% 6/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	22.2% 6/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Respiratory, thoracic and mediastinal disorders common cold	20.0% 5/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	25.9% 7/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Respiratory, thoracic and mediastinal disorders coughing	36.0% 9/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	33.3% 9/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Gastrointestinal disorders diarrhea	16.0% 4/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	22.2% 6/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
General disorders edema	20.0% 5/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	11.1% 3/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Gastrointestinal disorders heartburn	20.0% 5/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	7.4% 2/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Gastrointestinal disorders nausea	32.0% 8/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	14.8% 4/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Infections and infestations sore throat	4.0% 1/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	25.9% 7/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	20.0% 5/25 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.	18.5% 5/27 • The trial design is 13 visits over 27 months. Adverse events assessed at each encounter with subject.

Additional Information

Ron Hogg, M.D.

Saint Joseph's Hospital and Medical Center

Phone: 602-406-3246

Email: ronhogg@gmail.com

Results disclosure agreements

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