Trial Outcomes & Findings for Calcineurin Inhibitor Sparing After Kidney Transplantation (NCT NCT01062555)
NCT ID: NCT01062555
Last Updated: 2020-12-14
Results Overview
The percentage of patients alive at 6 month post transplant.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
527 participants
Primary outcome timeframe
6 months
Results posted on
2020-12-14
Participant Flow
All patients consented at time of transplant for phase 1. At 6 months post-transplant, patients were re-consented for phase 2. All patients represented for phase 2 were included for phase 1. Patients who were not re-consented for phase 2, were followed for 7 years under phase 1 protocol.
Participant milestones
| Measure |
Phase I Arm 1
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase II Arm 1
Low CNI and MMF
Low Dose CNI (Cyclosporine or FK) and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase II Arm 2
Rapa and MMF
Rapamune and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
266
|
261
|
0
|
0
|
|
Phase 1
COMPLETED
|
243
|
235
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
23
|
26
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
86
|
87
|
|
Phase 2
COMPLETED
|
0
|
0
|
71
|
53
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
15
|
34
|
Reasons for withdrawal
| Measure |
Phase I Arm 1
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase II Arm 1
Low CNI and MMF
Low Dose CNI (Cyclosporine or FK) and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase II Arm 2
Rapa and MMF
Rapamune and Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|---|---|
|
Phase 1
Death
|
10
|
17
|
0
|
0
|
|
Phase 1
Graft Failure
|
12
|
8
|
0
|
0
|
|
Phase 1
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Phase 2
Death
|
0
|
0
|
8
|
3
|
|
Phase 2
Graft failure
|
0
|
0
|
7
|
4
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
7
|
|
Phase 2
Protocol Violation
|
0
|
0
|
0
|
3
|
|
Phase 2
Physician Decision
|
0
|
0
|
0
|
17
|
Baseline Characteristics
This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
Baseline characteristics by cohort
| Measure |
Arm1 (Phase 1 & 2)
n=266 Participants
Participants from Phase 1, Arm 1 (CSA and MMF) and participants from Phase 2, Arm 1 (Low CNI and MMF)
|
Arm 2 (Phase 1 & 2)
n=261 Participants
Participants from Phase 1, Arm 2 (FK and MMF) and participants from Phase 2, Arm 2 (Rapa and MMF)
|
Total
n=527 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Phase 1 · <=18 years
|
0 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
1 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
1 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Age, Categorical
Phase 1 · Between 18 and 65 years
|
214 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
215 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
429 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Age, Categorical
Phase 1 · >=65 years
|
52 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
45 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
97 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Age, Categorical
Phase 2 · <=18 years
|
0 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Age, Categorical
Phase 2 · Between 18 and 65 years
|
67 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
74 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
141 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Age, Categorical
Phase 2 · >=65 years
|
19 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
13 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
32 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Sex: Female, Male
Phase 1 · Female
|
89 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
94 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
183 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Sex: Female, Male
Phase 1 · Male
|
177 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
167 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
344 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Sex: Female, Male
Phase 2 · Female
|
23 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
31 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
54 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Sex: Female, Male
Phase 2 · Male
|
63 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
56 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
119 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · American Indian or Alaska Native
|
6 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
9 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
15 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · Asian
|
18 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
13 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
31 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
2 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · Black or African American
|
19 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
12 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
31 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · White
|
221 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
227 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
448 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · More than one race
|
0 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
0 Participants
n=266 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=261 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=527 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · American Indian or Alaska Native
|
1 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
4 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
5 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · Asian
|
2 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
7 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
9 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · Black or African American
|
6 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
6 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
12 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · White
|
77 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
70 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
147 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · More than one race
|
0 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Race (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
0 Participants
n=86 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=87 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
0 Participants
n=173 Participants • This study had a sequential enrollment. Not all of the participants from phase one moved on to phase two, which is why phase two has a smaller number of participants analyzed.
|
|
Region of Enrollment
United States
|
266 participants
n=266 Participants
|
261 participants
n=261 Participants
|
527 participants
n=527 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe percentage of patients alive at 6 month post transplant.
Outcome measures
| Measure |
Phase I Arm 1
n=266 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=261 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase I: The Minimization of Negative Side Effects - Patient Survival
|
99 percentage of participants
|
98 percentage of participants
|
PRIMARY outcome
Timeframe: up to 7 yearsThe percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Outcome measures
| Measure |
Phase I Arm 1
n=86 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=87 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase II: The Minimization of Negative Side Effects - Patient Survival
|
89 percentage of participants
|
85 percentage of participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent of participants at 6 months with a functioning graft (without graft failure).
Outcome measures
| Measure |
Phase I Arm 1
n=266 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=261 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase I: The Minimization of Negative Side Effects - Graft Survival
|
99 percentage of participants
|
99 percentage of participants
|
PRIMARY outcome
Timeframe: up to 7 yearsThe percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Outcome measures
| Measure |
Phase I Arm 1
n=86 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=87 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase II: The Minimization of Negative Side Effects - Graft Survival
|
80 percentage of participants
|
78 percentage of participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent of participants at 6 months without acute rejection.
Outcome measures
| Measure |
Phase I Arm 1
n=266 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=261 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase I: Acute Rejection-Free Survival
|
80 percentage of participants
|
85 percentage of participants
|
PRIMARY outcome
Timeframe: up to 7 yearsThe percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Outcome measures
| Measure |
Phase I Arm 1
n=86 Participants
CSA and MMF
Cyclosporine \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
Phase I Arm 2
n=87 Participants
FK and MMF
Prograf \& Cellcept: Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
|
|---|---|---|
|
Phase II: Acute Rejection-Free Survival
|
76 percentage of participants
|
81 percentage of participants
|
Adverse Events
Phase I Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Phase I Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
Phase II Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Phase II Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place