Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00492869
First received: June 26, 2007
Last updated: February 26, 2009
Last verified: February 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 26, 2007 | ||||
| Last Updated Date | February 26, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00492869 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Kidney Transplantation | ||||
| Intervention ICMJE | Drug: AEB071 | ||||
| Study Arm (s) | |||||
| Publications * | Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. Epub 2011 May 12. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 124 | ||||
| Completion Date | |||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
Other protocol-defined inclusion/exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Belgium, Canada, Germany, Spain, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00492869 | ||||
| Other Study ID Numbers ICMJE | CAEB071A2207 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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