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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
| Genzyme, a Sanofi Company | INDUSTRY |
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Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.
It is clear that minimizing the use of CNIs may be beneficial to some or all kidney transplant recipients. The purpose of this study is to determine whether minimization of these CNI drugs will improve patient survival rates and long-term kidney function.
If the subject agrees to participate in this research project, they will be randomly assigned to one of two different immunosuppression drug combinations. All of the drugs used in this study are standard FDA Approved immunosuppressive drugs currently in use by transplant patients. It is unclear however, which combination provides a better long-term outcome.
If after six months of being on the study the subject has not experienced a rejection episode that excludes them from participating in the second phase of this study, they will asked whether or not they would like to continue the study. If they decide to participate in Phase II, there will be another randomization to one of two different immunosuppression drug combinations. This will involve either being assigned to a group that will have their CNI dose lowered or a group that will have their CNI drug stopped and replaced with a non-CNI drug called Sirolimus. Phase II begins at 6 months post-transplant and a second consent will be obtained for those who participate in Phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: The Minimization of Negative Side Effects - Patient Survival | The percentage of patients alive at 6 month post transplant. | 6 months |
| Phase II: The Minimization of Negative Side Effects - Patient Survival | 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. | up to 7 years |
| Phase I: The Minimization of Negative Side Effects - Graft Survival | Percent of participants at 6 months with a functioning graft (without graft failure). | 6 months |
| Phase II: The Minimization of Negative Side Effects - Graft Survival | 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. | up to 7 years |
| Phase I: Acute Rejection-Free Survival | Percent of participants at 6 months without acute rejection. | 6 months |
| Phase II: Acute Rejection-Free Survival | 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. | up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Matas, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
|
| ||||||||||||||||||
| Phase 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm1 (Phase 1 & 2) | Participants from Phase 1, Arm 1 (CSA and MMF) and participants from Phase 2, Arm 1 (Low CNI and MMF) |
| BG001 | Arm 2 (Phase 1 & 2) | Participants from Phase 1, Arm 2 (FK and MMF) and participants from Phase 2, Arm 2 (Rapa and MMF) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I: The Minimization of Negative Side Effects - Patient Survival | The percentage of patients alive at 6 month post transplant. | Posted | Number | percentage of participants | 6 months |
|
Phase 1 - 6 months Phase 2 - 7 years
Non-serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Matas | University of Minenesota | 612-625-5151 | matas001@umn.edu |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D003524 | Cyclosporins |
| D016559 | Tacrolimus |
| C485557 | cni protein, Drosophila |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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|
| 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. |
|
|
| Graft Failure |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Phase II: The Minimization of Negative Side Effects - Patient Survival | 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. | Posted | Number | percentage of participants | up to 7 years |
|
|
|
| Primary | Phase I: The Minimization of Negative Side Effects - Graft Survival | Percent of participants at 6 months with a functioning graft (without graft failure). | Posted | Number | percentage of participants | 6 months |
|
|
|
| Primary | Phase II: The Minimization of Negative Side Effects - Graft Survival | 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. | Posted | Number | percentage of participants | up to 7 years |
|
|
|
| Primary | Phase I: Acute Rejection-Free Survival | Percent of participants at 6 months without acute rejection. | Posted | Number | percentage of participants | 6 months |
|
|
|
| Primary | Phase II: Acute Rejection-Free Survival | 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. | Posted | Number | percentage of participants | up to 7 years |
|
|
|
| 10 |
| 266 |
| 0 |
| 266 |
| 0 |
| 0 |
| EG001 | 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. | 17 | 261 | 0 | 261 | 0 | 0 |
| EG002 | 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. | 8 | 86 | 0 | 86 | 0 | 0 |
| EG003 | 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. | 3 | 87 | 0 | 87 | 0 | 0 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|