EUCTR2011-005238-21-FR
Active, not recruiting
Phase 1
12 month, multi-center, open-label, prospective, randomized, parallel group study investigating a standard regimen in de novo kidney transplant patients versus a Certican® based regimen either in combination with Cyclosporin A or Tacrolimus - ATHENA
ovartis Pharma GmbH0 sites612 target enrollmentApril 22, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma GmbH
- Enrollment
- 612
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female renal allograft recipients at least 18 years old
- •2\.Patient who has received a primary or secondary kidney transplant from a deceased or living unrelated\-/related donor
- •3\.Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
- •4\.Recipient of a kidney allograft with a cold ischemia time (CIT) \< 30 hours
- •5\.Female patients who are menstruating and capable of becoming pregnant must have a negative pregnancy test prior to study enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 120
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Multi\-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •2\.Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •3\.Patients receiving a kidney from a non\-heart beating donor
- •4\.Patients who are recipients of A\-B\-0 incompatible transplants
- •5\.Patients with a current Panel Reactive Antibody (PRA) level of \> 20% (PRA levels within 4 months prior to enrollment) or patients with a positive Luminex test for any antigen of the donor
- •6\.Patients with already existing antibodies against the HLA\-type of the receiving transplant (in the knowledge of the investigator at the time point of transplantation)
- •7\.Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients
- •8\.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half\-lives of enrollment, whichever is longer
- •9\.Patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dL
- •10\.Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
Outcomes
Primary Outcomes
Not specified
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