Trial Outcomes & Findings for Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant (NCT NCT01239472)
NCT ID: NCT01239472
Last Updated: 2020-02-07
Results Overview
Cd106(VCAM-1) , IP-10/CXCL10, MIG/CXCL9, MCP-1/CCL2, IL-1, RANTES, IL-8, IL12p70, TNF, IL-10, IL-6, IL-1, VEGF, FGF, CD54(ICAM-1) were analysed in urine 90 days after transplant (before randomization), and 365 days after transplant. Material were conserved at -80 Celsius, and analysed by ELISA at same time. Data was shown in MFI units
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Urine and biopsy data are collected 90 days and 365 days after transplant.
Results posted on
2020-02-07
Participant Flow
Participant milestones
| Measure |
Tacrolimus
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone the whole study
|
Everolimus
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, whom switched tacrolimus to everolimus 90 days after renal transplantation. Since then the patients kept taking everolimus, mycophenolate sodium and prednisone
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Tacrolimus
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone the whole study
|
Everolimus
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, whom switched tacrolimus to everolimus 90 days after renal transplantation. Since then the patients kept taking everolimus, mycophenolate sodium and prednisone
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Baseline characteristics by cohort
| Measure |
Tacrolimus
n=10 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone with low immunologic risk .
|
Everolimus
n=12 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone with low immunologic risk, and converted for use of mycophenolate sodium, everolimus, and prednisone after 90 days of kidney transplantation.
|
Total
n=22 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
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Urine and biopsy data are collected 90 days and 365 days after transplant.Population: 15 patients were enrolled in each group. However in "tacrolimus" group 5 patients didn't want to be submitted to other biopsy and to collect urine 365 days after transplant. And in "everolimus" group 3 patients had adverse events and was switched back to tacrolimus.
Cd106(VCAM-1) , IP-10/CXCL10, MIG/CXCL9, MCP-1/CCL2, IL-1, RANTES, IL-8, IL12p70, TNF, IL-10, IL-6, IL-1, VEGF, FGF, CD54(ICAM-1) were analysed in urine 90 days after transplant (before randomization), and 365 days after transplant. Material were conserved at -80 Celsius, and analysed by ELISA at same time. Data was shown in MFI units
Outcome measures
| Measure |
Tacrolimus
n=10 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, during the whole study. This is the no intervention group.
|
Everolimus
n=12 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone at beginning, but whom switched tacrolimus to everolimus at 90 days after transplant. This is the intervention group
|
|---|---|---|
|
Cytokines Evaluation
FGF 365days
|
30 MFI
Interval 26.0 to 37.0
|
29 MFI
Interval 23.0 to 31.0
|
|
Cytokines Evaluation
CD106 90days
|
43222 MFI
Interval 33422.0 to 59960.0
|
28564 MFI
Interval 9732.0 to 55116.0
|
|
Cytokines Evaluation
CD106 365days
|
18324 MFI
Interval 12261.0 to 54026.0
|
19614 MFI
Interval 11721.0 to 26523.0
|
|
Cytokines Evaluation
CD54 90days
|
1512 MFI
Interval 746.0 to 2594.0
|
1293 MFI
Interval 666.0 to 4206.0
|
|
Cytokines Evaluation
CD54 365days
|
696 MFI
Interval 217.0 to 1321.0
|
1664 MFI
Interval 1309.0 to 2319.0
|
|
Cytokines Evaluation
IL6 365days
|
281 MFI
Interval 223.0 to 418.0
|
262 MFI
Interval 237.0 to 281.0
|
|
Cytokines Evaluation
IL1 90days
|
212 MFI
Interval 194.0 to 234.0
|
215 MFI
Interval 195.0 to 224.0
|
|
Cytokines Evaluation
IL1 365days
|
228 MFI
Interval 209.0 to 258.0
|
228 MFI
Interval 226.0 to 242.0
|
|
Cytokines Evaluation
VEGF 90days
|
82 MFI
Interval 67.0 to 107.0
|
70 MFI
Interval 57.0 to 140.0
|
|
Cytokines Evaluation
VEGF 365days
|
84 MFI
Interval 46.0 to 141.0
|
45 MFI
Interval 33.0 to 58.0
|
|
Cytokines Evaluation
FGF 90days
|
39 MFI
Interval 35.0 to 44.0
|
43 MFI
Interval 37.0 to 48.0
|
|
Cytokines Evaluation
TNF 365days
|
153 MFI
Interval 150.0 to 164.0
|
157 MFI
Interval 151.0 to 167.0
|
|
Cytokines Evaluation
IL10 90days
|
155 MFI
Interval 150.0 to 168.0
|
164 MFI
Interval 160.0 to 173.0
|
|
Cytokines Evaluation
IL10 365 days
|
179 MFI
Interval 168.0 to 188.0
|
182 MFI
Interval 177.0 to 186.0
|
|
Cytokines Evaluation
IL6 90days
|
282 MFI
Interval 224.0 to 334.0
|
349 MFI
Interval 224.0 to 349.0
|
|
Cytokines Evaluation
IL8 90days
|
495 MFI
Interval 328.0 to 804.0
|
624 MFI
Interval 409.0 to 1019.0
|
|
Cytokines Evaluation
IL8 365days
|
641 MFI
Interval 327.0 to 1874.0
|
435 MFI
Interval 321.0 to 558.0
|
|
Cytokines Evaluation
IL12 90days
|
116 MFI
Interval 110.0 to 121.0
|
124 MFI
Interval 111.0 to 130.0
|
|
Cytokines Evaluation
IL12 365days
|
124 MFI
Interval 119.0 to 133.0
|
124 MFI
Interval 119.0 to 138.0
|
|
Cytokines Evaluation
TNF 90days
|
136 MFI
Interval 134.0 to 145.0
|
146 MFI
Interval 141.0 to 161.0
|
|
Cytokines Evaluation
IP10 90days
|
380 MFI
Interval 261.0 to 900.0
|
893 MFI
Interval 194.0 to 1825.0
|
|
Cytokines Evaluation
IP10 365days
|
763 MFI
Interval 88.0 to 1668.0
|
147 MFI
Interval 127.0 to 353.0
|
|
Cytokines Evaluation
MCP1 90days
|
2349 MFI
Interval 1751.0 to 3234.0
|
4119 MFI
Interval 2652.0 to 7529.0
|
|
Cytokines Evaluation
MCP1 365days
|
1306 MFI
Interval 750.0 to 7259.0
|
1375 MFI
Interval 790.0 to 3342.0
|
|
Cytokines Evaluation
MIG 90days
|
396 MFI
Interval 239.0 to 673.0
|
433 MFI
Interval 249.0 to 1925.0
|
|
Cytokines Evaluation
MIG 365days
|
287 MFI
Interval 153.0 to 964.0
|
580 MFI
Interval 262.0 to 1090.0
|
|
Cytokines Evaluation
RANTES 90days
|
148 MFI
Interval 134.0 to 167.0
|
145 MFI
Interval 134.0 to 212.0
|
|
Cytokines Evaluation
RANTES 365days
|
144 MFI
Interval 134.0 to 199.0
|
155 MFI
Interval 151.0 to 165.0
|
SECONDARY outcome
Timeframe: 90 days after transplant and 365 days after transplantEvaluation of renal function (serum creatinine) 90 days after transplant and 365 days after transplant.
Outcome measures
| Measure |
Tacrolimus
n=10 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, during the whole study. This is the no intervention group.
|
Everolimus
n=12 Participants
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone at beginning, but whom switched tacrolimus to everolimus at 90 days after transplant. This is the intervention group
|
|---|---|---|
|
Evaluation of Renal Function
Cr 365days
|
1.4 mg/dL
Interval 1.22 to 1.65
|
1.4 mg/dL
Interval 0.95 to 1.47
|
|
Evaluation of Renal Function
Cr 90days
|
1.6 mg/dL
Interval 1.2 to 1.7
|
1.3 mg/dL
Interval 1.05 to 1.66
|
Adverse Events
Tacrolimus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Everolimus
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus
n=15 participants at risk
Kidney transplant patients starting taking tacrolimus, mycophenolate sodium and prednisone, and keeping it the whole study.
|
Everolimus
n=15 participants at risk
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, and whom switched tacrolimus to everolimus 90 days after renal transplantation. Therefore the patients were taking everolimus, mycophenolate sodium and prednisone since 90 days after the transplant, and kept this way during the whole study
|
|---|---|---|
|
Renal and urinary disorders
graft failure
|
0.00%
0/15 • Adverse events data were collected during the followup of the study, which was done until the last biopsy, 1 year after transplant.
Because the access to patients and files by the PI were limited as previous explained, serious adverses events were considered all cause mortality, and graft failure. Other adverse event was biopsy acute rejection. Withdrawn of the study by patient option, or because everolimus serum level was not reached, was recorded but not considered a adverse event. Hospitalizations were not considered adverse events because sometimes it weren't recorded by the office, and not reported to the PI.
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected during the followup of the study, which was done until the last biopsy, 1 year after transplant.
Because the access to patients and files by the PI were limited as previous explained, serious adverses events were considered all cause mortality, and graft failure. Other adverse event was biopsy acute rejection. Withdrawn of the study by patient option, or because everolimus serum level was not reached, was recorded but not considered a adverse event. Hospitalizations were not considered adverse events because sometimes it weren't recorded by the office, and not reported to the PI.
|
Other adverse events
| Measure |
Tacrolimus
n=15 participants at risk
Kidney transplant patients starting taking tacrolimus, mycophenolate sodium and prednisone, and keeping it the whole study.
|
Everolimus
n=15 participants at risk
Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, and whom switched tacrolimus to everolimus 90 days after renal transplantation. Therefore the patients were taking everolimus, mycophenolate sodium and prednisone since 90 days after the transplant, and kept this way during the whole study
|
|---|---|---|
|
Renal and urinary disorders
biopsy proven acute rejection
|
0.00%
0/15 • Adverse events data were collected during the followup of the study, which was done until the last biopsy, 1 year after transplant.
Because the access to patients and files by the PI were limited as previous explained, serious adverses events were considered all cause mortality, and graft failure. Other adverse event was biopsy acute rejection. Withdrawn of the study by patient option, or because everolimus serum level was not reached, was recorded but not considered a adverse event. Hospitalizations were not considered adverse events because sometimes it weren't recorded by the office, and not reported to the PI.
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected during the followup of the study, which was done until the last biopsy, 1 year after transplant.
Because the access to patients and files by the PI were limited as previous explained, serious adverses events were considered all cause mortality, and graft failure. Other adverse event was biopsy acute rejection. Withdrawn of the study by patient option, or because everolimus serum level was not reached, was recorded but not considered a adverse event. Hospitalizations were not considered adverse events because sometimes it weren't recorded by the office, and not reported to the PI.
|
Additional Information
Dr Andre Barreto Pereira
Hospital e Maternidade Marieta Konder Bornhausen
Phone: +55 47 984482826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place