Trial Outcomes & Findings for Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome (NCT NCT02390362)
NCT ID: NCT02390362
Last Updated: 2019-03-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
3 participants
Primary outcome timeframe
6 months
Results posted on
2019-03-26
Participant Flow
Only one site enrolled.
Participant milestones
| Measure |
Rituximab
Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 \& 3.
Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF
|
Mycophenolate Mofetil (MMF)
Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months
MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Rituximab
Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 \& 3.
Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF
|
Mycophenolate Mofetil (MMF)
Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months
MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome
Baseline characteristics by cohort
| Measure |
Rituximab
n=1 Participants
Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 \& 3.
Rituximab: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF
|
Mycophenolate Mofetil (MMF)
n=2 Participants
Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months
MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Study terminated early. Only three subjects were enrolled and results will not be posted to protect subject confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study terminated early. Only 3 subjects enrolled. Data will not be posted to protect the subject identity.
Outcome measures
Outcome data not reported
Adverse Events
Rituximab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mycophenolate Mofetil (MMF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William E. Smoyer, MD.
The Research Institute at Nationwide Children's Hospital
Phone: 6147222683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place