Trial Outcomes & Findings for A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients. (NCT NCT00758602)
NCT ID: NCT00758602
Last Updated: 2014-08-04
Results Overview
CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (\~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (\>)50% cell infiltration); interstitial fibrosis (0=none, 1=\~25% interstitial affected, 2=26-50% interstitial affected, and 3=\>50% interstitial affected); tubular atrophy (0=none, 1=\~15% proximal tubular atrophy \[PTA\], 2=16-30% PTA, and 3=\>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis \[NGS\] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=\>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=\~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=\>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (\<)25% remaining artery/small artery membrane \[RA/SAM\], 2=EP to 26-50% \[RA/SAM\], and 3=\>50% \[RA/SAM\]). CADI score was the sum of the 6 histological findings.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
210 participants
Primary outcome timeframe
Month 12
Results posted on
2014-08-04
Participant Flow
Participant milestones
| Measure |
Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus
Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
106
|
|
Overall Study
COMPLETED
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
Reasons for withdrawal
| Measure |
Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus
Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Reason not specified
|
3
|
3
|
Baseline Characteristics
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Baseline characteristics by cohort
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 10.16 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.
CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (\~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (\>)50% cell infiltration); interstitial fibrosis (0=none, 1=\~25% interstitial affected, 2=26-50% interstitial affected, and 3=\>50% interstitial affected); tubular atrophy (0=none, 1=\~15% proximal tubular atrophy \[PTA\], 2=16-30% PTA, and 3=\>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis \[NGS\] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=\>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=\~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=\>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (\<)25% remaining artery/small artery membrane \[RA/SAM\], 2=EP to 26-50% \[RA/SAM\], and 3=\>50% \[RA/SAM\]). CADI score was the sum of the 6 histological findings.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=57 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=52 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
|
1.82 score on a scale
Standard Deviation 1.974
|
2.13 score on a scale
Standard Deviation 2.000
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.
GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance \[milliliters per minute (mL/min)\] = \[(140 minus age) multiplied by (\*) (body weight in kg) divided by \[72 \* serum creatinine mg per deciliter (mg/dL)\]. For females, creatinine clearance (mL/min) = 0.85 \* \[(140 minus age) \* (body weight in kg)\] divided by \[72 \* serum creatinine (mg/dL)\].
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=86 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=82 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
|
77.08 mL/min
Standard Deviation 18.250
|
80.12 mL/min
Standard Deviation 18.362
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: ITT population
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Acute rejection, 6 months post-transplant
|
2.6 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Acute rejection, 12 months post-transplant
|
2.6 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Graft loss, 6 months post-transplant
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Graft loss, 12 months post-transplant
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Death, 6 months post-transplant
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Death, 12 months post-transplant
|
0.0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 2, 4, 13, 26, 39, and 52Population: ITT population
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: BL, Weeks 2, 4, 13, 26, 39, and 52Population: ITT population
The median time, in days, between randomization and acute rejection.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Time to First Acute Rejection Post-Transplant
|
40 days
Interval 13.0 to 67.0
|
18 days
Interval 5.0 to 95.0
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population
Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
|
9.6 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: ITT population
The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Participant and Graft Survival
6 months post-transplant
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Participant and Graft Survival
12 months post-transplant
|
100.0 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 2, 4, 13, 26, 39, and 52Population: ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.
The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Baseline (n=95,96)
|
662.93 µmol/L
Standard Deviation 351.913
|
639.70 µmol/L
Standard Deviation 287.044
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 2 (n=101,102)
|
154.57 µmol/L
Standard Deviation 151.374
|
115.71 µmol/L
Standard Deviation 52.648
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 4 (n=99,98)
|
118.47 µmol/L
Standard Deviation 76.134
|
107.08 µmol/L
Standard Deviation 32.668
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 13 (n=88,91)
|
97.52 µmol/L
Standard Deviation 24.947
|
100.10 µmol/L
Standard Deviation 25.345
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 26 (n=84,83)
|
105.70 µmol/L
Standard Deviation 45.403
|
97.51 µmol/L
Standard Deviation 21.997
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 39 (n=83,77)
|
102.22 µmol/L
Standard Deviation 38.035
|
95.16 µmol/L
Standard Deviation 20.877
|
|
Serum Creatinine (Micromoles Per Liter [µmol/L])
Week 52 (n=86,82)
|
103.10 µmol/L
Standard Deviation 48.251
|
94.19 µmol/L
Standard Deviation 21.964
|
SECONDARY outcome
Timeframe: BL, Weeks 2, 4, 13, 26, 39, and 52Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.
Outcome measures
| Measure |
MMF, Standard Dose Tacrolimus
n=104 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 Participants
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 4 (n=99,98)
|
71.77 mL/min
Standard Deviation 23.578
|
72.87 mL/min
Standard Deviation 19.934
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 13 (n=88,91)
|
78.13 mL/min
Standard Deviation 18.686
|
75.71 mL/min
Standard Deviation 17.906
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 26 (n=84,83)
|
75.92 mL/min
Standard Deviation 21.046
|
76.77 mL/min
Standard Deviation 17.536
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Baseline (n=95,96)
|
14.37 mL/min
Standard Deviation 8.080
|
15.41 mL/min
Standard Deviation 13.759
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 2 (n=101,102)
|
67.95 mL/min
Standard Deviation 30.140
|
71.02 mL/min
Standard Deviation 22.177
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 39 (n=83,77)
|
77.34 mL/min
Standard Deviation 19.046
|
78.00 mL/min
Standard Deviation 16.036
|
|
Glomerular Filtration Rate (GFR) (mL/Min)
Week 52 (n=86,82)
|
77.08 mL/min
Standard Deviation 18.250
|
80.12 mL/min
Standard Deviation 18.362
|
Adverse Events
MMF, Standard Dose Tacrolimus
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
MMF, Low Dose Tacrolimus
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MMF, Standard Dose Tacrolimus
n=104 participants at risk
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 participants at risk
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Cardiac disorders
Sudden death
|
0.00%
0/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Renal and urinary disorders
Acute rejection
|
0.96%
1/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Renal and urinary disorders
Transplanted renal rupture
|
0.00%
0/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Infections and infestations
Cytomegalovirus (CMV) disease
|
0.00%
0/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
Other adverse events
| Measure |
MMF, Standard Dose Tacrolimus
n=104 participants at risk
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
MMF, Low Dose Tacrolimus
n=106 participants at risk
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
|
|---|---|---|
|
Investigations
Alanine transaminase (ALT) increased
|
9.6%
10/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
11.3%
12/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Blood and lymphatic system disorders
White blood cell (WBC) count decreased
|
8.7%
9/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
8.5%
9/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
4/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
7.5%
8/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Renal and urinary disorders
Serum creatinine increased
|
4.8%
5/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
3.8%
4/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Investigations
Aspartate transamininase (AST) increased
|
3.8%
4/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
2.8%
3/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Investigations
Hyperlipemia
|
2.9%
3/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
3.8%
4/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Endocrine disorders
New-onset diabetes
|
2.9%
3/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
1.9%
2/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Gastrointestinal disorders
Pyrosis
|
0.00%
0/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
3.8%
4/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.96%
1/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Investigations
Hypercholesterolemia
|
0.96%
1/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.94%
1/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.96%
1/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
0.00%
0/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
|
General disorders
Others - not specified
|
8.7%
9/104 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
7.5%
8/106 • Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
All randomized participants were included in the safety analysis.
|
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