Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01062555 | Calcineurin Inhibitor Sparing After Kidney Transplantation | PHASE1 | COMPLETED | 527 | — | — | Oct 1, 2006 | Apr 3, 2014 | Dec 14, 2020 | 1 | United States |
The percentage of patients alive at 6 month post transplant.
The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Percent of participants at 6 months with a functioning graft (without graft failure).
The 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.
Percent of participants at 6 months without acute rejection.
The 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.
| Arm | Type | Description |
|---|---|---|
| Phase I Arm 1 | ACTIVE_COMPARATOR | CSA and MMF |
| Phase I Arm 2 | ACTIVE_COMPARATOR | FK and MMF |
| Phase II Arm 1 | ACTIVE_COMPARATOR | Low CNI and MMF |
| Phase II Arm 2 | ACTIVE_COMPARATOR | Rapa and MMF |
| Name | Type | Description |
|---|---|---|
| Cyclosporine & Cellcept | DRUG | 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. |
| Prograf & Cellcept | DRUG | 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. |
| Low Dose CNI (Cyclosporine or FK) and Cellcept | DRUG | 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. |
| Rapamune and Cellcept | DRUG | 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. |
Inclusion Criteria: * Kidney Transplant Recipients \> 18 years old * First or Second Kidney Transplant only Exclusion Criteria: * Kidney Transplant Recipients \< 18 years old * Kidney Transplant Recipients who have a history of \> 2 kidney transplants * Kidney Transplant Recipients with an alread...