Kidney Transplantation Clinical Trial
Official title:
A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
| NCT number | NCT00492869 |
| Other study ID # | CAEB071A2207 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| First received | |
| Last updated | |
| Start date | January 2007 |
| Verified date | September 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion: - Male and female patients of any race 18 years or older - Adult recipients of kidney transplant from a deceased or living donor - Recipients of a functioning kidney within 24 hours post transplant Exclusion: - Need for medication prohibited by the protocol - Patients or donors infected with Hepatitis B,C or HIV - Patients with a history of cancer within last 5 years - Patients with history of significant cardiac disorder - Patients of high-risk immunological status Other protocol-defined inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Erasme | Bruxelles | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | Queen Elizabeth II | Halifax | |
| Canada | Saint Joseph's Hospital | Hamilton | Ontario |
| Canada | Hopital Maisonneuve-Rosemont | Montreal Quebec | |
| Germany | Klinikum der Humboldt Universitat Charite | Berlin | |
| Germany | Universitaetsklinik Charité | Berlin | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Univ.-Klinikum Heidelberg | Heidelberg | |
| Germany | Staedt. Kliniken Koeln-Merheim | Koeln | |
| Germany | Klinikum der Universitaet Regensburg | Regensburg | |
| Spain | Fundacion Puigvert | Barcelona | |
| Spain | Hospital Juan Canalejo | La Coruna | |
| Sweden | Enheten f Transpl och Leverkir, SU/Sahlgrenska | Goteborg | |
| Sweden | Transplantationskirurgiska mottagningen, Akademiska Sjukhuse | Uppsala | |
| United Kingdom | Addenbrookes Hospital | Cambridge | |
| United Kingdom | Leicester General Hospital | Leicester | |
| United Kingdom | Churchill Hospital | Oxford | |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | U of Maryland Medical Center | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | University of Cincinnati, Dept of Internal Medicine | Cincinnati | Ohio |
| United States | Baylor U Medical Center | Dallas | Texas |
| United States | University of Colorado Health Science Center | Denver | Colorado |
| United States | Henry Ford Hospital Transplant Institute | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University of Texas Medical Branch at Galveston | Galveston | Texas |
| United States | Saint Barnabas Medical Center | Livingston | New Jersey |
| United States | USC Medical Center | Los Angeles | California |
| United States | U of Wisconsin Hospital Clinics | Madison | Wisconsin |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Comprehensive Transplant Clinic | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | University of Pennsylvania Health System-Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | University of Utah | Salt Lake City | Utah |
| United States | University of California San Diego | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | UCSF | San Francisco | California |
| United States | Lifelink, Inc. | Tampa | Florida |
| United States | University of Toledo Health Science Campus | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Belgium, Canada, Germany, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms | |||
| Secondary | Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies |
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