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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.
This study will evaluate:
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus, steroid avoidance arm | Experimental | Thymoglobulin induction, sirolimus and no maintenance corticosteroid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Thymoglobulin induction, sirolimus and no maintenance corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative One-year Acute Rejection Rates | To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant | 12 months |
| One-year Graft Survival | To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival | 12 months |
| One-year Patient Survival | To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post Transplant Diabetes | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus | 12 months |
| Drug-treated Dyslipidemic Syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akinlolu Ojo, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus, Steroid Avoidance Arm | Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
From the 49 consented, 5 were not begun on treatment or removed very early on for clinical reasons, so they are not included in baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus, Steroid Avoidance Arm | Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cumulative One-year Acute Rejection Rates | To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant | Posted | Count of Participants | Participants | 12 months |
|
|
1 year follow up
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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 | Sirolimus, Steroid Avoidance Arm | Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Akinlolu Ojo, Professor of Medicine | University of Michigan | 734 9364890 | aojo@umich.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome |
| 12 months |
| Blood Pressure Control | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | One-year Graft Survival | To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Primary | One-year Patient Survival | To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Incidence of Post Transplant Diabetes | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Drug-treated Dyslipidemic Syndrome | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Blood Pressure Control | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |