Kidney Transplantation Clinical Trial
Official title:
Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids
Verified date | January 2011 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
Status | Completed |
Enrollment | 342 |
Est. completion date | May 2005 |
Est. primary completion date | May 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Males and females aged 18 to 75 years. - Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression. Exclusion Criteria: - Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ. - Kidneys from non-heart beating donors or HLA identical living related donors. - ABO incompatibility against the donor. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Cordoba | Cordoba | |
Argentina | Unidad de Transplante Velez Sarsfield | Cordoba | |
Argentina | Crai Norte | San Martin | Buenos Aires |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Monash Medical Centre | Clayton | Victoria |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | The Queen Elizabeth Hospital | Woodville | South Australia |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Brazil | Hospital das Clinicas - UNICAMP | Campinas | SP |
Brazil | Hipertensao Hospital do Rim e Hipertensao | Sao Paulo | SP |
Canada | Foothills Medical Center | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Queen II Health and Science Center | Halifax | Nova Scotia |
Canada | McGill University Health Centre | Montreal | Quebec |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | University Health Network, The Toronto Hospital | Toronto | Ontario |
Germany | Klinikum der Johann Wolfgang Geothe-Universitaet | Frankfurt am Main | |
Germany | Staedt. Krankenhaus Koeln-Merheim | Koeln | |
Italy | Ospedale Consorziale e policlinico-Universita degli Studi | Bari | BA |
Malaysia | Hospital Kuala Lumpur | Kuala Lumpur | |
New Zealand | Auckland Hospital | Auckland | Grafton |
Singapore | Singapore General Hospital | Singapore | |
Spain | Hospital de Bellvitge | L'hospitalet de Llobregat | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Central de Asturias | Oviedo | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | ROC |
Taiwan | Chang-Gung Memorial Hospital-Linko | Tao-Yuan | Lin-Ko |
United Kingdom | Queen Elizabeth Medical Centre | Edgbaston | Birmingham |
United Kingdom | University Hospital of Wales | Heath Park | Cardiff |
United Kingdom | Freeman Hospital | High Heaton | Newcastle Upon Tyne |
United Kingdom | Guy's Hospital | London | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United Kingdom | Walsgrave Hospital NHS Trust | Walsgrave | Coventry |
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | University Hospitals of Cleveland, Division of Nephrology | Cleveland | Ohio |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Indiana U. Medical Center | Indianapolis | Indiana |
United States | U. of Wisconsin Hospital Clinics | Madison | Wisconsin |
United States | Loyola Medical Center | Maywood | Illinois |
United States | Legacy Research & Technology Ctr. | Portland | Oregon |
United States | UCSF Kidney Transplant Service | San Francisco | California |
United States | Livelink, Inc. | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Australia, Brazil, Canada, Germany, Italy, Malaysia, New Zealand, Singapore, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calculated glomerular filtration rate after 12 months treatment | |||
Secondary | Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months. | |||
Secondary | Patient and graft survival after 12 months. | |||
Secondary | Incidence of AEs and SAEs after 3 and 12 months. | |||
Secondary | Blood pressure, lipids and glucose profiles after 3 and 12 months. | |||
Secondary | Percentage of patients free of steroids at 12 months |
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