Trial Outcomes & Findings for An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil (NCT NCT01672957)
NCT ID: NCT01672957
Last Updated: 2016-10-11
Results Overview
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
COMPLETED
128 participants
Month 1
2016-10-11
Participant Flow
If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.
Participant milestones
| Measure |
Renal Transplant Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
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|---|---|
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Overall Study
STARTED
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128
|
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Overall Study
Intent-to-treat (ITT) Population
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123
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Overall Study
COMPLETED
|
73
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Overall Study
NOT COMPLETED
|
55
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Reasons for withdrawal
| Measure |
Renal Transplant Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
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|---|---|
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Overall Study
Protocol Violation
|
48
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Overall Study
Death
|
2
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Overall Study
ICF Signed After Transplantation
|
5
|
Baseline Characteristics
An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
Baseline characteristics by cohort
| Measure |
Renal Transplant Participants
n=123 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Age, Continuous
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49.60 years
STANDARD_DEVIATION 13.24 • n=93 Participants
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Sex: Female, Male
Female
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44 Participants
n=93 Participants
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Sex: Female, Male
Male
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79 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Outcome measures
| Measure |
Renal Transplant Participants
n=107 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Creatinine Clearance at 1 Month After Transplantation
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65.82 mL/min
Standard Deviation 18.32
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PRIMARY outcome
Timeframe: Month 6Population: ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Outcome measures
| Measure |
Renal Transplant Participants
n=76 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Creatinine Clearance at Month 6 After Transplantation
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73.38 mL/min
Standard Deviation 19.43
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PRIMARY outcome
Timeframe: Month 12Population: ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Outcome measures
| Measure |
Renal Transplant Participants
n=70 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Creatinine Clearance at Month 12 After Transplantation
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69.69 mL/min
Standard Deviation 21.05
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PRIMARY outcome
Timeframe: Month 1Population: ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\<) 15 mL/min indicates kidney failure.
Outcome measures
| Measure |
Renal Transplant Participants
n=118 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Glomerular Filtration Rate (GFR) at Month 1 After Transplantation
|
53.54 mL/min
Standard Deviation 33.43
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PRIMARY outcome
Timeframe: Month 6Population: ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
Outcome measures
| Measure |
Renal Transplant Participants
n=83 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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GFR at Month 6 After Transplantation
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56.78 mL/min
Standard Deviation 15.36
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PRIMARY outcome
Timeframe: Month 12Population: ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
Outcome measures
| Measure |
Renal Transplant Participants
n=65 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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GFR at Month 12 After Transplantation
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58.03 mL/min
Standard Deviation 16.29
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SECONDARY outcome
Timeframe: Baseline, Months 1, 6, and 12Population: ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Outcome measures
| Measure |
Renal Transplant Participants
n=121 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Mean Dose of Mycophenolate Mofetil
Baseline (n=121)
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2033.06 milligrams (mg)
Standard Deviation 357.86
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Mean Dose of Mycophenolate Mofetil
Month 1 (n=119)
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1718.49 milligrams (mg)
Standard Deviation 543.21
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Mean Dose of Mycophenolate Mofetil
Month 6 (n=88)
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1457.39 milligrams (mg)
Standard Deviation 754.51
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Mean Dose of Mycophenolate Mofetil
Month 12 (n=69)
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1539.86 milligrams (mg)
Standard Deviation 669.21
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SECONDARY outcome
Timeframe: Baseline, Months 1, 6, and 12Population: ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
Outcome measures
| Measure |
Renal Transplant Participants
n=121 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
3 Other agents: at Month 1 (n=119)
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0 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
1 Other agent: at baseline (n=121)
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0.8 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
1 Other agent: at Month 1 (n=119)
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0.8 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
1 Other agent: at Month 6 (n=86)
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2.3 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
1 Other agent: at Month 12 (n=69)
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7.2 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
2 Other agents: at baseline (n=121)
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90.9 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
2 Other agents: at Month 1 (n=119)
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99.2 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
2 Other agents: at Month 6 (n=86)
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97.7 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
2 Other agents: at Month 12 (n=69)
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92.8 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
3 Other agents: at baseline (n=121)
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8.3 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
3 Other agents: at Month 6 (n=86)
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0 percentage of participants
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Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
3 Other agents: at Month 12 (n=69)
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0 percentage of participants
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SECONDARY outcome
Timeframe: Baseline to Month 1, Months 2 to 6, Months 7 to 12Population: Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
Outcome measures
| Measure |
Renal Transplant Participants
n=127 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Percentage of Participants With Acute Rejection
Baseline to Month 1 (n=127)
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16.5 percentage of participants
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Percentage of Participants With Acute Rejection
Months 2 to 6 (n=124)
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0.8 percentage of participants
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Percentage of Participants With Acute Rejection
Months 7 to 12 (n=111)
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0.9 percentage of participants
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SECONDARY outcome
Timeframe: Months 1, 6, and 12Population: Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 weeks), re-transplant or death during the first 12 months after transplantation.
Outcome measures
| Measure |
Renal Transplant Participants
n=127 Participants
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Percentage of Participants With Graft Survival
Month 1 (n=127)
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100 percentage of participants
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Percentage of Participants With Graft Survival
Month 6 (n=123)
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99.2 percentage of participants
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Percentage of Participants With Graft Survival
Month 12 (n=111)
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98.4 percentage of participants
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Adverse Events
Renal Transplant Participants
Serious adverse events
| Measure |
Renal Transplant Participants
n=128 participants at risk
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
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|---|---|
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Cardiac disorders
Acute myocardial infarction
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
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Gastrointestinal disorders
Diarrhoea
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
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General disorders
Sudden death
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
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Immune system disorders
Kidney transplant rejection
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3.1%
4/128 • From Baseline up to Month 12
Safety population.
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Immune system disorders
Transplant rejection
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10.9%
14/128 • From Baseline up to Month 12
Safety population.
|
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Infections and infestations
Cystitis
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
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Infections and infestations
Influenza
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Infections and infestations
Pneumonia
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2.3%
3/128 • From Baseline up to Month 12
Safety population.
|
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Infections and infestations
Postoperative abscess
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
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1.6%
2/128 • From Baseline up to Month 12
Safety population.
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
1.6%
2/128 • From Baseline up to Month 12
Safety population.
|
|
Investigations
Blood creatinine increased
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0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
1.6%
2/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Ureteral disorder
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Reproductive system and breast disorders
Varicocele
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
|
Vascular disorders
Haematoma
|
1.6%
2/128 • From Baseline up to Month 12
Safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/128 • From Baseline up to Month 12
Safety population.
|
Other adverse events
| Measure |
Renal Transplant Participants
n=128 participants at risk
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
19/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Hyperuricaemia
|
5.5%
7/128 • From Baseline up to Month 12
Safety population.
|
|
Renal and urinary disorders
Urinary tract infection
|
18.8%
24/128 • From Baseline up to Month 12
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.8%
10/128 • From Baseline up to Month 12
Safety population.
|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
13/128 • From Baseline up to Month 12
Safety population.
|
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