Trial Outcomes & Findings for A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis (NCT NCT02081183)
NCT ID: NCT02081183
Last Updated: 2014-07-17
Results Overview
Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
18 months
Results posted on
2014-07-17
Participant Flow
Protocol Approved by National Regulatory Agency on 25 October 2005 and inclusion period ended on 21 January 2008, on three investigational sites but only two sites included patients. Sites were selected in public health care systems.
Screening period include only the assessments to verified the inclusion and exclusion criteria's from ICF signature until base line visit (first dose day), no washout or run in period was expected.
Participant milestones
| Measure |
Mycophenolate Mofetil (MMF), Prednisone
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
Cyclophosphamide, Prednisone
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Mycophenolate Mofetil (MMF), Prednisone
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
Cyclophosphamide, Prednisone
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other
|
3
|
3
|
Baseline Characteristics
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
Baseline characteristics by cohort
| Measure |
MMF, Prednisone
n=5 Participants
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
Cyclophosphamide, Prednisone
n=6 Participants
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 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
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Venezuela
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Data were not analyzed because the study was terminated early.
Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 18 monthsPopulation: Data were not analyzed because the study was terminated early.
Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 18 monthsPopulation: Data were not analyzed because the study was terminated early.
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 18 monthsPopulation: Data were not analyzed because the study was terminated early.
Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.
Outcome measures
Outcome data not reported
Adverse Events
MMF, Prednisone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cyclophosphamide, Prednisone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MMF, Prednisone
n=5 participants at risk
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
Cyclophosphamide, Prednisone
n=6 participants at risk
Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m\^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase.
|
|---|---|---|
|
Nervous system disorders
Cephalea
|
0.00%
0/5 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
16.7%
1/6 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
16.7%
1/6 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
33.3%
2/6 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
|
General disorders
Chills
|
0.00%
0/5 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
16.7%
1/6 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
|
General disorders
Swelling
|
0.00%
0/5 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
16.7%
1/6 • Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER