Trial Outcomes & Findings for Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy (NCT NCT01282073)
NCT ID: NCT01282073
Last Updated: 2025-08-27
Results Overview
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
at 48 week after treatment
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
Mycophenolate Mofetil, Low Dose Steroid
Mycophenolate mofetil, low dose steroid: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg)
Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day
Duration: 48 weeks
|
Cyclosporin, Low Dose Steroid
Cyclosporin, low dose steroid: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)
Steroid: same dosage with active comparator goup
Duration: 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
Baseline characteristics by cohort
| Measure |
Mycophenolate Mofetil, Low Dose Steroid
n=21 Participants
Mycophenolate mofetil, low dose steroid: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
|
Cyclosporin, Low Dose Steroid
n=18 Participants
Cyclosporin, low dose steroid: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
21 participants
n=93 Participants
|
18 participants
n=4 Participants
|
39 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at 48 week after treatmentComplete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Outcome measures
| Measure |
Mycophenolate Mofetil, Low Dose Steroid
n=21 Participants
Mycophenolate mofetil, low dose steroid: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
|
Cyclosporin, Low Dose Steroid
n=18 Participants
Cyclosporin, low dose steroid: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks
|
|---|---|---|
|
Percentage of Complete Remission
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: at 48 week after treatmentPartial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day
Outcome measures
| Measure |
Mycophenolate Mofetil, Low Dose Steroid
n=21 Participants
Mycophenolate mofetil, low dose steroid: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
|
Cyclosporin, Low Dose Steroid
n=18 Participants
Cyclosporin, low dose steroid: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks
|
|---|---|---|
|
Percentage of Partial Remission
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: at 48 week after treatmentThe change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For 48 weeks after treatmentA relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 48 week after treatmentThe change of proteinuria from baseline to 48 week after treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For 48 weeks after treatmentAny undesired effects of interventional drugs
Outcome measures
Outcome data not reported
Adverse Events
Mycophenolate Mofetil, Low Dose Steroid
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cyclosporin, Low Dose Steroid
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mycophenolate Mofetil, Low Dose Steroid
n=21 participants at risk
Mycophenolate mofetil, low dose steroid: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
|
Cyclosporin, Low Dose Steroid
n=18 participants at risk
Cyclosporin, low dose steroid: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • 48 weeks
|
11.1%
2/18 • 48 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
14.3%
3/21 • 48 weeks
|
22.2%
4/18 • 48 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • 48 weeks
|
5.6%
1/18 • 48 weeks
|
|
Infections and infestations
Upper respiratory infection
|
28.6%
6/21 • 48 weeks
|
16.7%
3/18 • 48 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • 48 weeks
|
0.00%
0/18 • 48 weeks
|
|
Infections and infestations
Skin infection
|
9.5%
2/21 • 48 weeks
|
5.6%
1/18 • 48 weeks
|
|
Endocrine disorders
New onset diabetes mellitus
|
4.8%
1/21 • 48 weeks
|
5.6%
1/18 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy
|
4.8%
1/21 • 48 weeks
|
5.6%
1/18 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place